BINAXNOW COVID-19 AG SELF TEST 4CT
Report
- Report Number
- 1221359-2024-00653
- Event Type
- Malfunction
- Date Received
- October 21, 2024
- Date of Event
- October 2, 2024
- Report Date
- November 29, 2024
- Manufacturer
- ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
- Product Code
- QKP
- UDI-DI
- 00811877011729
- PMA / PMN Number
- EUA210264
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
CORRECTED DATA: AWARENESS DATE OF THIS EVENT IS (B)(6) 2024. G3 - DATE RECEIVED BY MFG ON REPORT 1221359-2024-00653-00 SHOULD BE 05OCT2024. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 870976B WITH INTERNAL POSITIVE QUALITY CONTROL SAMPLES AND NEGATIVE QUALITY CONTROL SWABS. ALL TEST RESULTS WERE VALID AND PERFORMED AS EXPECTED. ADDITIONALLY, THE MANUFACTURING RECORDS AND QUALITY CONTROL RELEASE TESTING WAS REVIEWED FOR TEST KIT PART NUMBER 195-180/ LOT 870976B AND TEST BASE PART NUMBER 195-430WJR/ LOT 870976. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 870976B SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE, HOWEVER, IT COULD POSSIBLY BE RELATED TO ISSUES INCLUDING THE SELF-TEST USER PERFORMANCE, INTERPRETATION OF THE RESULT, OR THE SPECIFIC PATIENT SAMPLE.
THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION OR UPON RECEIPT OF NEW INFORMATION.
CORRECTED DATA - B5 - DESCRIBE EVENT OR PROBLEM / D4 - SERIAL # TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 870976B WITH INTERNAL POSITIVE QUALITY CONTROL SAMPLES AND NEGATIVE QUALITY CONTROL SWABS. ALL TEST RESULTS WERE VALID AND PERFORMED AS EXPECTED. ADDITIONALLY, THE MANUFACTURING RECORDS AND QUALITY CONTROL RELEASE TESTING WAS REVIEWED FOR TEST KIT PART NUMBER 195-180/ LOT 870976B AND TEST BASE PART NUMBER 195-430WJR/ LOT 870976. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 870976B SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE, HOWEVER, IT COULD POSSIBLY BE RELATED TO ISSUES INCLUDING THE SELF-TEST USER PERFORMANCE, INTERPRETATION OF THE RESULT, OR THE SPECIFIC PATIENT SAMPLE.
THE CONSUMER REPORTED SIX FALSE NEGATIVE RESULTS WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON VARIOUS DATES. THIS MANUFACTURER¿S REPORT ADDRESSES PATIENT 1 (TEST QTY 4), TEST TWO (2) OF SIX OF (6). THE CONSUMER PERFORMED A BINAXNOW COVID-19 ANTIGEN SELF-TEST ON (B)(6) 2024 AND GENERATED A NEGATIVE RESULT. ADDITIONAL TESTING WAS PERFORMED WITH THE CVS COVID-19 TEST KIT ON 03OCT2024 AND GENERATED A POSITIVE RESULT. THE CONSUMER WAS EXPERIENCING COUGH, SNEEZING AND FEVER AND CONTACTED THE DOCTOR SINCE HE HAS COPD, WHICH HAD THE SAME SYMPTOMS AS COVID-19. THE CONSUMER WAS ALSO TAKING PAXLOVID. THE CONSUMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS.
THE CONSUMER REPORTED TWO FALSE NEGATIVE RESULTS WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON (B)(6) 2024. THIS MANUFACTURER'S REPORT ADDRESSES TEST TWO (2) OF TWO (2). CONSUMER PERFORMED TWO ADDITIONAL BINAXNOW COVID-19 ANTIGEN SELF-TESTS ON UNKNOWN DATES AND GENERATED POSITIVE RESULTS. ADDITIONAL TESTING WAS PERFORMED WITH THE (B)(6) COVID-19 TEST KIT ON (B)(6) 2024 AND GENERATED A POSITIVE RESULT. THE CONSUMER WAS EXPERIENCING COUGH, SNEEZING AND FEVER AND CONTACTED THE DOCTOR SINCE HE HAS COPD WHICH HAD THE SAME SYMPTOMS AS COVID-19. THE CONSUMER WAS ALSO TAKING PAXLOVID. THE CONSUMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS.
THE CONSUMER REPORTED SIX FALSE NEGATIVE RESULTS WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON VARIOUS DATES. THIS MANUFACTURER¿S REPORT ADDRESSES PATIENT 1 (QTY 4), TEST TWO (2) OF SIX OF (6). THE CONSUMER PERFORMED A BINAXNOW COVID-19 ANTIGEN SELF-TEST ON (B)(6) 2024 AND GENERATED A NEGATIVE RESULT. ADDITIONAL TESTING WAS PERFORMED WITH THE(B)(6) ON (B)(6) 2024 AND GENERATED A POSITIVE RESULT. THE CONSUMER WAS EXPERIENCING COUGH, SNEEZING AND FEVER AND CONTACTED THE DOCTOR SINCE HE HAS COPD, WHICH HAD THE SAME SYMPTOMS AS COVID-19. THE CONSUMER WAS ALSO TAKING PAXLOVID. THE CONSUMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1043596 | BINAXNOW COVID-19 AG SELF TEST 4CT | CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | QKP | ABBOTT DIAGNOSTICS SCARBOROUGH, INC. | 870976B | 00811877011729 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Male |