Freedom of Information on number of PCR tests and Lateral flow test reports received by MHRA during the period 01/01/2020-31/03/2022 (FOI 22/459)
Published 1 June 2022
漏 Crown copyright 2022
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FOI 22/459
8th March 2022
Dear
Thank you for highlighting the points around the data provided in response to your FOI request.
On review of the data extract, it became clear that you had identified an error. I confirm that there were a number of typing errors which occurred when transferring data from the MHRA database into the tables of data provided to you in our response to your request. Please accept my apologies for these errors, which were unintentional.
Please see below the corrected and updated data tables. I have also taken the opportunity to update February 2022 data to cover the complete month and have included data for the month of March 2022 also.
Notes to understanding the data:
The data is not specific to a particular manufacturer. The number of reports is accurate at the time they were taken from our database on 7th April 2022, and minor changes in the numbers can occur if the reporter of the incident gives us more details later.
The inclusion of a report on our adverse incident database does not necessarily mean the events described were caused by that听medical听device but could be due to unrelated patient/user factors. Moreover, the information we hold on our database is not a full picture of all the device-related incidents that happened during this period, it is just a snapshot.
Therefore, our data should not be used to make a judgement on the safety of this type of testing device or how likely an adverse incident may occur when using this type of device.
The reason for reporting can be just a suspicion that an incident or adverse effect was caused by a device or the way in which it was being used. Reports might be related to events which resulted in no injury, minor injury or a death or serious deterioration in health or the potential for these events to occur.
It is not compulsory for healthcare professionals and members of the public to report incidents directly to MHRA, but we strongly encourage this.
Total number of reports received in the period 01/01/2020-31/03/2022: 3445
Number of reports received by MHRA during the period 01/01/2020-31/03/2022 broken down by year, month received and type of test. Please note the PCR test data includes sample collection kits:
| 听听听听 Month/Year听听听 | 听听听听 PCR tests听听听 | 听听听听 Lateral flow tests听听听 | ||
|---|---|---|---|---|
| 听听听听 2020听听听听听听听听听 | 听听听听听听听听听听听听听听听听听 | 听听听听听听听听听听听听听听听听听听听听听听听听听听 | 听听 | 听 |
| 听听听听 April听听听听听听听听 | 听听听听 <5听听听听听听听听听听 | 听听听听 0听听听听听听听听听听听听听听听听听听听听 | 听听 | 听 |
| 听听听听 May听听听听听听听听听听 | 听听听听 5听听听听听听听听听听听 | 听听听听 0听听听听听听听听听听听听听听听听听听听听 | 听听 | 听 |
| 听听听听 June听听听听听听听听听 | 听听听听 10听听听听听听听听听听 | 听听听听 0听听听听听听听听听听听听听听听听听听听听 | 听 | 听 |
| 听听听听 July听听听听听听听听听 | 听听听听 77听听听听听听听听听听 | 听听听听 0听听听听听听听听听听听听听听听听听听听听 | 听听 | 听 |
| 听听听听 August听听听听听听听 | 听听听听 125听听听听听听听听听 | 听听听听 0听听听听听听听听听听听听听听听听听听听听 | 听听 | 听 |
| 听听听听 September听听听听 | 听听听听 162听听听听听听听听听 | 听听听听 0听听听听听听听听听听听听听听听听听听听听 | 听听 | 听 |
| 听听听听 October听听听听听听 | 听听听听 137听听听听听听听听听 | 听听听听 0听听听听听听听听听听听听听听听听听听听听 | 听听 | 听 |
| 听听听听 November听听听听听 | 听听听听 104听听听听听听听听听 | 听听听听 <5听听听听听听听听听听听听听听听听听听听 | 听听 | 听 |
| 听听听听 December听听听听听 | 听听听听 97听听听听听听听听听听 | 听听听听 23听听听听听听听听听听听听听听听听听听听 | 听听 | 听 |
| 听听听听 2021听听听听听听听听听 | 听听听听听听听听听听听听听听听听听 | 听听听听听听听听听听听听听听听听听听听听听听听听听听 | 听听 | 听 |
| 听听听听 January听听听听听听 | 听听听听 110听听听听听听听听听 | 听听听听 34听听听听听听听听听听听听听听听听听听听 | 听听 | 听 |
| 听听听听 February听听听听听 | 听听听听 138听听听听听听听听听 | 听听听听 68听听听听听听听听听听听听听听听听听听听 | 听听 | 听 |
| 听听听听 March听听听听听听听听 | 听听听听 119听听听听听听听听听 | 听听听听 117听听听听听听听听听听听听听听听听听听 | 听听 | 听 |
| 听听听听 April听听听听听听听听 | 听听听听 100听听听听听听听听听 | 听听听听 95听听听听听听听听听听听听听听听听听听听 | 听听 | 听 |
| 听听听听 May听听听听听听听听听听 | 听听听听 91听听听听听听听听听听 | 听听听听 54听听听听听听听听听听听听听听听听听听听 | 听 | 听 |
| 听听听听 June听听听听听听听听听 | 听听听听 150听听听听听听听听听 | 听听听听 41听听听听听听听听听听听听听听听听听听听 | 听听 | 听 |
| 听听听听 July听听听听听听听听听 | 听听听听 117听听听听听听听听听 | 听听听听 42听听听听听听听听听听听听听听听听听听听 | 听听 | 听 |
| 听听听听 August听听听听听听听 | 听听听听 98听听听听听听听听听听 | 听听听听 26听听听听听听听听听听听听听听听听听听听 | 听听 | 听 |
| 听听听听 September听听听听 | 听听听听 172听听听听听听听听听 | 听听听听 56听听听听听听听听听听听听听听听听听听听 | 听听 | 听 |
| 听听听听 October听听听听听听 | 听听听听 133听听听听听听听听听 | 听听听听 38听听听听听听听听听听听听听听听听听听听 | 听 | 听 |
| 听听听听 November听听听听听 | 听听听听 136听听听听听听听听听 | 听听听听 61听听听听听听听听听听听听听听听听听听听 | 听听 | 听 |
| 听听听听 December听听听听听 | 听听听听 169听听听听听听听听听 | 听听听听 149听听听听听听听听听听听听听听听听听听 | 听听 | 听 |
| 听听听听 2022听听听听听听听听听 | 听听听听听听听听听听听听听听听听听 | 听听听听听听听听听听听听听听听听听听听听听听听听听听 | 听听 | 听 |
| 听听听听 January听听听听听听 | 听听听听 105听听听听听听听听听 | 听听听听 119听听听听听听听听听听听听听听听听听听 | 听听 | 听 |
| 听听听听 February听听听听听 | 听听听听 45听听听听听听听听听听 | 听听听听 71听听听听听听听听听听听听听听听听听听听 | 听听 | 听 |
| 听听听听 March听听听听听听听听 | 听听听听 29听听听听听听听听听听 | 听听听听 18听听听听听听听听听听听听听听听听听听听 | 听 | 听 |
Number of reports received broken down by the year and month they were reported to MHRA and indicating the reported level of harm for PCR tests, this includes the sample collection kits:
| 听听听听 Month/Year听听听 | 听听听听 None听听听 | 听听听听 Minor听听听 | 听听听听 Serious听听听 | 听听听听 Death听听听 |
|---|---|---|---|---|
| 听听听听 2020听听听听听听听听听 | 听听听听听听听听听听听听 | 听听听听听听听听听听听听听 | 听听听听听听听听听听听听听听听 | 听听听听听听听听听听听听听 |
| 听听听听 April听听听听听听听听 | 听听听听 0听听听听听听 | 听听听听 <5听听听听听听 | 听听听听 0听听听听听听听听听 | 听听听听 0听听听听听听听 |
| 听听听听 May听听听听听听听听听听 | 听听听听 <5听听听听听 | 听听听听 <5听听听听听听 | 听听听听 <5听听听听听听听听 | 听听听听 0听听听听听听听 |
| 听听听听 June听听听听听听听听听 | 听听听听 9听听听听听听 | 听听听听 <5听听听听听听 | 听听听听 0听听听听听听听听听 | 听听听听 0听听听听听听听 |
| 听听听听 July听听听听听听听听听 | 听听听听 69听听听听听 | 听听听听 6听听听听听听听 | 听听听听 <5听听听听听听听听 | 听听听听 0听听听听听听听 |
| 听听听听 August听听听听听听听 | 听听听听 120听听听听 | 听听听听 <5听听听听听听 | 听听听听 <5听听听听听听听听 | 听听听听 0听听听听听听听 |
| 听听听听 September听听听听 | 听听听听 156听听听听 | 听听听听 <5听听听听听听 | 听听听听 <5听听听听听听听听 | 听听听听 0听听听听听听听 |
| 听听听听 October听听听听听听 | 听听听听 126听听听听 | 听听听听 10听听听听听听 | 听听听听 <5听听听听听听听听 | 听听听听 0听听听听听听听 |
| 听听听听 November听听听听听 | 听听听听 90听听听听听 | 听听听听 <5听听听听听听 | 听听听听 10听听听听听听听听 | 听听听听 0听听听听听听听 |
| 听听听听 December听听听听听 | 听听听听 79听听听听听 | 听听听听 11听听听听听听 | 听听听听 7听听听听听听听听听 | 听听听听 0听听听听听听听 |
| 听听听听 2021听听听听听听听听听 | 听听听听听听听听听听听听 | 听听听听听听听听听听听听听 | 听听听听听听听听听听听听听听听 | 听听听听听听听听听听听听听 |
| 听听听听 January听听听听听听 | 听听听听 76听听听听听 | 听听听听 19听听听听听听 | 听听听听 15听听听听听听听听 | 听听听听 0听听听听听听听 |
| 听听听听 February听听听听听 | 听听听听 94听听听听听 | 听听听听 27听听听听听听 | 听听听听 16听听听听听听听听 | 听听听听 <5听听听听听听 |
| 听听听听 March听听听听听听听听 | 听听听听 99听听听听听 | 听听听听 13听听听听听听 | 听听听听 6听听听听听听听听听 | 听听听听 <5听听听听听听 |
| 听听听听 April听听听听听听听听 | 听听听听 80听听听听听 | 听听听听 16听听听听听听 | 听听听听 <5听听听听听听听听 | 听听听听 0听听听听听听听 |
| 听听听听 May听听听听听听听听听听 | 听听听听 77听听听听听 | 听听听听 10听听听听听听 | 听听听听 <5听听听听听听听听 | 听听听听 0听听听听听听听 |
| 听听听听 June听听听听听听听听听 | 听听听听 130听听听听 | 听听听听 15听听听听听听 | 听听听听 5听听听听听听听听听 | 听听听听 0听听听听听听听 |
| 听听听听 July听听听听听听听听听 | 听听听听 95听听听听听 | 听听听听 19听听听听听听 | 听听听听 <5听听听听听听听听 | 听听听听 0听听听听听听听 |
| 听听听听 August听听听听听听听 | 听听听听 84听听听听听 | 听听听听 13听听听听听听 | 听听听听 <5听听听听听听听听 | 听听听听 0听听听听听听听 |
| 听听听听 September听听听听 | 听听听听 149听听听听 | 听听听听 20听听听听听听 | 听听听听 <5听听听听听听听听 | 听听听听 <5听听听听听听 |
| 听听听听 October听听听听听听 | 听听听听 106听听听听 | 听听听听 21听听听听听听 | 听听听听 6听听听听听听听听听 | 听听听听 0听听听听听听听 |
| 听听听听 November听听听听听 | 听听听听 111听听听听 | 听听听听 24听听听听听听 | 听听听听 <5听听听听听听听听 | 听听听听 0听听听听听听听 |
| 听听听听 December听听听听听 | 听听听听 147听听听听 | 听听听听 20听听听听听听 | 听听听听 <5听听听听听听听听 | 听听听听 0听听听听听听听 |
| 听听听听 2022听听听听听听听听听 | 听听听听听听听听听听听听 | 听听听听听听听听听听听听听 | 听听听听听听听听听听听听听听听 | 听听听听听听听听听听听听听 |
| 听听听听 January听听听听听听 | 听听听听 93听听听听听 | 听听听听 9听听听听听听听 | 听听听听 <5听听听听听听听听 | 听听听听 0听听听听听听听 |
| 听听听听 February听听听听听 | 听听听听 42听听听听听 | 听听听听 <5听听听听听听 | 听听听听 0听听听听听听听听听 | 听听听听 0听听听听听听听 |
| 听听听听 March听听听听听听听听 | 听听听听 26听听听听听 | 听听听听 <5听听听听听听 | 听听听听 0听听听听听听听听听 | 听听听听 0听听听听听听听 |
Number of reports received broken down by the year and month they were reported to MHRA and indicating the reported level of harm for rapid antigen Lateral Flow tests:
| 听听听听 Month/Year听听听 | 听听听听 None听听听 | 听听听听 Minor听听听 | 听听听听 Serious听听听 | 听听听听 Death听听听 |
|---|---|---|---|---|
| 听听听听 2020听听听听听听听听听 | 听听听听听听听听听听听听 | 听听听听听听听听听听听听听 | 听听听听听听听听听听听听听听听 | 听听听听听听听听听听听听听 |
| 听听听听 November听听听听听 | 听听听听 <5听听听听听 | 听听听听 0听听听听听听听 | 听听听听 0听听听听听听听听听 | 听听听听 0听听听听听听听 |
| 听听听听 December听听听听听 | 听听听听 21听听听听听 | 听听听听 0听听听听听听听 | 听听听听 <5听听听听听听听听 | 听听听听 0听听听听听听听 |
| 听听听听 2021听听听听听听听听听 | 听听听听听听听听听听听听 | 听听听听听听听听听听听听听 | 听听听听听听听听听听听听听听听 | 听听听听听听听听听听听听听 |
| 听听听听 January听听听听听听 | 听听听听 28听听听听听 | 听听听听 5听听听听听听听 | 听听听听 <5听听听听听听听听 | 听听听听 0听听听听听听听 |
| 听听听听 February听听听听听 | 听听听听 51听听听听听 | 听听听听 13听听听听听听 | 听听听听 <5听听听听听听听听 | 听听听听 0听听听听听听听 |
| 听听听听 March听听听听听听听听 | 听听听听 83听听听听听 | 听听听听 23听听听听听听 | 听听听听 11听听听听听听听听 | 听听听听 0听听听听听听听 |
| 听听听听 April听听听听听听听听 | 听听听听 74听听听听听 | 听听听听 16听听听听听听 | 听听听听 <5听听听听听听听听 | 听听听听 <5听听听听听听 |
| 听听听听 May听听听听听听听听听听 | 听听听听 41听听听听听 | 听听听听 10听听听听听听 | 听听听听 <5听听听听听听听听 | 听听听听 0听听听听听听听 |
| 听听听听 June听听听听听听听听听 | 听听听听 32听听听听听 | 听听听听 8听听听听听听听 | 听听听听 <5听听听听听听听听 | 听听听听 0听听听听听听听 |
| 听听听听 July听听听听听听听听听 | 听听听听 27听听听听听 | 听听听听 15听听听听听听 | 听听听听 0听听听听听听听听听 | 听听听听 0听听听听听听听 |
| 听听听听 August听听听听听听听 | 听听听听 17听听听听听 | 听听听听 7听听听听听听听 | 听听听听 <5听听听听听听听听 | 听听听听 0听听听听听听听 |
| 听听听听 September听听听听 | 听听听听 33听听听听听 | 听听听听 19听听听听听听 | 听听听听 <5听听听听听听听听 | 听听听听 0听听听听听听听 |
| 听听听听 October听听听听听听 | 听听听听 25听听听听听 | 听听听听 12听听听听听听 | 听听听听 <5听听听听听听听听 | 听听听听 0听听听听听听听 |
| 听听听听 November听听听听听 | 听听听听 40听听听听听 | 听听听听 15听听听听听听 | 听听听听 6听听听听听听听听听 | 听听听听 0听听听听听听听 |
| 听听听听 December听听听听听 | 听听听听 132听听听听 | 听听听听 14听听听听听听 | 听听听听 <5听听听听听听听听 | 听听听听 0听听听听听听听 |
| 听听听听 2022听听听听听听听听听 | 听听听听听听听听听听听听 | 听听听听听听听听听听听听听 | 听听听听听听听听听听听听听听听 | 听听听听听听听听听听听听听 |
| 听听听听 January听听听听听听 | 听听听听 97听听听听听 | 听听听听 18听听听听听听 | 听听听听 <5听听听听听听听听 | 听听听听 0听听听听听听听 |
| 听听听听 February听听听听听 | 听听听听 65听听听听听 | 听听听听 <5听听听听听听 | 听听听听 <5听听听听听听听听 | 听听听听 0听听听听听听听 |
| 听听听听 March听听听听听听听听 | 听听听听 13听听听听听 | 听听听听 <5听听听听听听 | 听听听听 <5听听听听听听听听 | 听听听听 0听听听听听听听 |
听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听 Number of reports received indicating the reported clinical effect:
| 听听听听 Type of issue reported听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听 | 听听听听 PCR tests听听听 | 听听听听 Lateral Flow tests听听听 | ||
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| 听听听听 No information provided in the report/Insufficient听听 information provided to determine clinical effect/could not be determined听听听 | 听听听听 2234听听听听听听听听 | 听听听听 991听听听听听听听听听听听听听听听听听听 | 听听 | 听听 |
| 听听听听 Headache听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听 | 听听听听 0听听听听听听听听听听听 | 听听听听 <5听听听听听听听听听听听听听听听听听听听 | 听听 | 听听 |
| 听听听听 Hypersensitivity/Allergic reaction听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听 | 听听听听 7听听听听听听听听听听听 | 听听听听 7听听听听听听听听听听听听听听听听听听听听 | 听听 | 听听 |
| 听听听听 Choking听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听 | 听听听听 8听听听听听听听听听听听 | 听听听听 5听听听听听听听听听听听听听听听听听听听听 | 听听 | 听听 |
| 听听听听 Epistaxis听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听 | 听听听听 <5听听听听听听听听听听 | 听听听听 <5听听听听听听听听听听听听听听听听听听听 | 听听 | 听听 |
| 听听听听 Respiratory tract infection听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听 | 听听听听 0听听听听听听听听听听听 | 听听听听 <5听听听听听听听听听听听听听听听听听听听 | 听听 | 听听 |
| 听听听听 Sore Throat听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听 | 听听听听 <5听听听听听听听听听听 | 听听听听 <5听听听听听听听听听听听听听听听听听听听 | 听听 | 听听 |
| 听听听听 Hot flashes/flushes听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听 | 听听听听 0听听听听听听听听听听听 | 听听听听 <5听听听听听听听听听听听听听听听听听听听 | 听听 | 听听 |
| 听听听听 Skin inflammation/irritation听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听 | 听听听听 0听听听听听听听听听听听 | 听听听听 <5听听听听听听听听听听听听听听听听听听听 | 听听 | 听听 |
| 听听听听 Swelling/Edema听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听 | 听听听听 <5听听听听听听听听听听 | 听听听听 <5听听听听听听听听听听听听听听听听听听听 | 听听 | 听听 |
| 听听听听 No clinical signs, symptoms or conditions reported听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听 | 听听听听 131听听听听听听听听听 | 听听听听 <5听听听听听听听听听听听听听听听听听听听 | 听听 | 听听 |
| 听听听听 Loss of consciousness听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听 | 听听听听 <5听听听听听听听听听听 | 听听听听 0听听听听听听听听听听听听听听听听听听听听 | 听听 | 听听 |
| 听听听听 Emotional changes听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听 | 听听听听 25听听听听听听听听听听 | 听听听听 0听听听听听听听听听听听听听听听听听听听听 | 听听 | 听听 |
| 听听听听 Asthma听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听 | 听听听听 <5听听听听听听听听听听 | 听听听听 0听听听听听听听听听听听听听听听听听听听听 | 听听 | 听听 |
| 听听听听 Chronic Obstructive Pulmonary Disorder (COPD)听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听 | 听听听听 <5听听听听听听听听听听 | 听听听听 0听听听听听听听听听听听听听听听听听听听听 | 听听 | 听听 |
| 听听听听 Cough听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听 | 听听听听 <5听听听听听听听听听听 | 听听听听 0听听听听听听听听听听听听听听听听听听听听 | 听听 | 听听 |
| 听听听听 Nasal obstruction听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听 | 听听听听 <5听听听听听听听听听听 | 听听听听 0听听听听听听听听听听听听听听听听听听听听 | 听听 | 听听 |
| 听听听听 Sneezing听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听 | 听听听听 <5听听听听听听听听听听 | 听听听听 0听听听听听听听听听听听听听听听听听听听听 | 听听 | 听听 |
| 听听听听 Vomiting听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听 | 听听听听 <5听听听听听听听听听听 | 听听听听 0听听听听听听听听听听听听听听听听听听听听 | 听听 | 听听 |
| 听听听听 Joint dislocation听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听 | 听听听听 <5听听听听听听听听听听 | 听听听听 0听听听听听听听听听听听听听听听听听听听听 | 听听 | 听听 |
| 听听听听 Foreign body in patient听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听 | 听听听听 <5听听听听听听听听听听 | 听听听听 0听听听听听听听听听听听听听听听听听听听听 | 听听 | 听听 |
| 听听听听 Fluid discharge听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听 | 听听听听 <5听听听听听听听听听听 | 听听听听 0听听听听听听听听听听听听听听听听听听听听 | 听听 | 听听 |
| 听听听听 Reaction to medicinal component of device听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听 | 听听听听 <5听听听听听听听听听听 | 听听听听 0听听听听听听听听听听听听听听听听听听听听 | 听听 | 听听 |
Number of reports with test kit issues:
| 听听听听 Type of issue reported听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听 | 听听听听 PCR tests听听听 | 听听听听 Lateral Flow tests听听听 | ||
|---|---|---|---|---|
| 听听听听 Manufacturing, Packaging or Shipping Problem听听听听听听听听听听听听听听听听听听听听听听听听听听 | 听听听听 1300听听听听听听听听 | 听听听听 253听听听听听听听听听听听听听听听听听听 | 听听 | 听听 |
| 听听听听 Output Problem听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听 | 听听听听 262听听听听听听听听听 | 听听听听 364听听听听听听听听听听听听听听听听听听 | 听听 | 听听 |
| 听听听听 Patient Device Interaction Problem听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听 | 听听听听 161听听听听听听听听听 | 听听听听 112听听听听听听听听听听听听听听听听听听 | 听听 | 听听 |
| 听听听听 No Apparent Adverse Event听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听 | 听听听听 154听听听听听听听听听 | 听听听听 94听听听听听听听听听听听听听听听听听听听 | 听听 | 听听 |
| 听听听听 Material Integrity Problem听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听 | 听听听听 144听听听听听听听听听 | 听听听听 20听听听听听听听听听听听听听听听听听听听 | 听听 | 听听 |
| 听听听听 Insufficient Information provided to determine type听听 of issue听听听听听听听听 | 听听听听 118听听听听听听听听听 | 听听听听 26听听听听听听听听听听听听听听听听听听听 | 听听 | 听听 |
| 听听听听 Mechanical Problem听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听 | 听听听听 94听听听听听听听听听听 | 听听听听 25听听听听听听听听听听听听听听听听听听听 | 听听 | 听听 |
| 听听听听 Labelling, Instructions for Use or Training Problem听听听听听听听听听听听听听听听听听听听 | 听听听听 60听听听听听听听听听听 | 听听听听 15听听听听听听听听听听听听听听听听听听听 | 听听 | 听听 |
| 听听听听 Adverse Event Without Identified Device or Use听听 Problem听听听听听听听听听听听听听听 | 听听听听 39听听听听听听听听听听 | 听听听听 16听听听听听听听听听听听听听听听听听听听 | 听听 | 听听 |
| 听听听听 Use of Device Problem听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听 | 听听听听 25听听听听听听听听听听 | 听听听听 58听听听听听听听听听听听听听听听听听听听 | 听听 | 听听 |
| 听听听听 Appropriate Term/Code Not Available听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听 | 听听听听 23听听听听听听听听听听 | 听听听听 12听听听听听听听听听听听听听听听听听听听 | 听听 | 听听 |
| 听听听听 Contamination / decontamination Problem听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听 | 听听听听 16听听听听听听听听听听 | 听听听听 <5听听听听听听听听听听听听听听听听听听听 | 听听 | 听听 |
| 听听听听 Computer Software Problem听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听 | 听听听听 9听听听听听听听听听听听 | 听听听听 7听听听听听听听听听听听听听听听听听听听听 | 听听 | 听听 |
| 听听听听 No Code Entered By Submitter/Blank听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听 | 听听听听 10听听听听听听听听听听 | 听听听听 5听听听听听听听听听听听听听听听听听听听听 | 听听 | 听听 |
| 听听听听 Infusion or Flow problem听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听 | 听听听听听听听听听听听听听听听听听 | 听听听听 6听听听听听听听听听听听听听听听听听听听听 | 听听 | 听听 |
| 听听听听 Chemical Problem听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听 | 听听听听 <5听听听听听听听听听听 | 听听听听 0听听听听听听听听听听听听听听听听听听听听 | 听听 | 听听 |
| 听听听听 Calibration problem听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听 | 听听听听 <5听听听听听听听听听听 | 听听听听 0听听听听听听听听听听听听听听听听听听听听 | 听听 | 听听 |
| 听听听听 Manufacturing, packaging or shipping problem & Material听听 Integrity听听听 | 听听听听 <5听听听听听听听听听听 | 听听听听 0听听听听听听听听听听听听听听听听听听听听 | 听听 | 听听 |
| 听听听听 Communication or Transmission problem听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听 | 听听听听 <5听听听听听听听听听听 | 听听听听 0听听听听听听听听听听听听听听听听听听听听 | 听听 | 听听 |
| 听听听听 Manufacturing, packaging or shipping problem &听听 Mechanical problem听听听 | 听听听听 <5听听听听听听听听听听 | 听听听听 0听听听听听听听听听听听听听听听听听听听听 | 听听 | 听听 |
| 听听听听 Protective measures problem听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听 | 听听听听 <5听听听听听听听听听听 | 听听听听 0听听听听听听听听听听听听听听听听听听听听 | 听听 | 听听 |
| 听听听听 Temperature problem听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听 | 听听听听 <5听听听听听听听听听听 | 听听听听 0听听听听听听听听听听听听听听听听听听听听 | 听听 | 听听 |
| 听听听听 Mechanical problem &Material integrity problem听听听听听听听听听听听听听听听听听听听听听听听听 | 听听听听 <5听听听听听听听听听听 | 听听听听 0听听听听听听听听听听听听听听听听听听听听 | 听听 | 听听 |
In answer to your specific questions:
- The first table suggests the MHRA received 988 to 992 reports of feedback/harm relating to lateral flow tests in total (uncertainty on exact figure due to the <5 for November 2020). But the third table suggests the MHRA received 1,029 to 1,081 reports that gave information on the level of harm reported (uncertainty due to <5 in table). Could you explain how this is the case? Shouldn鈥檛 the second figure should be the same or less than the first figure?
Please review the updated and corrected data tables which I believe will resolve this question.
- Does the fifth table on the number of reports with test kit issues on top of the data in the first table?
The data from the fifth table is taken from the same total number of reports received by MHRA. Reports may include details of test kit issues such as those listed in table 5 and also a number of clinical effects. Some reports contain very minimal data and these may contain blank fields or not enough information to assign a type of test kit issue.
- Or does the first table reflect the total number of PCR and lateral flow reports, and within those multiple harms were reported (which would explain why there are more reports of types of harm than overall reports) and also included reports of test kit issues, which would explain why there are more reports of test kit issues than overall reports?
The first table does reflect the total number of reports received by MHRA. A single report may include a single or a number of reported clinical effects and test kits issues or may contain blank fields or minimal information about the harm or clinical effect or test kit issue which has occurred.
I trust this information and explanation has been of use.
Yours sincerely
MHRA Customer Experience Centre
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU Telephone 0203 080 6000