BINAXNOW COVID-19 AG SELF TEST 2CT
Report
- Report Number
- 1221359-2023-01605
- Event Type
- Malfunction
- Date Received
- November 1, 2023
- Date of Event
- October 22, 2023
- Report Date
- January 10, 2024
- Manufacturer
- ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
- Product Code
- QKP
- UDI-DI
- 00811877011408
- PMA / PMN Number
- EUA210264
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
D4: UDI: (B)(4). TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 203111 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 195-160/LOT 203111, TEST BASE PART NUMBER 195-430H/LOT 198688. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 203111 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 HAVE POSSIBLY BEEN RELATED TO ISSUES INCLUDING THE SELF-TEST USER PERFORMANCE, INTERPRETATION OF THE RESULT, OR THE SPECIFIC PATIENT SAMPLE. H3 OTHER TEXT: SINGLE-USE, DEVICE DISCARDED.
ADDITIONAL INFORMATION: H2 D4 UDI: (B)(4) TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 203111 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 195-160 / LOT 203111, TEST BASE PART NUMBER 195-430H / LOT 198688. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 203111 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 HAVE POSSIBLY BEEN RELATED TO ISSUES INCLUDING THE SELF-TEST USER PERFORMANCE, INTERPRETATION OF THE RESULT, OR THE SPECIFIC PATIENT SAMPLE.H2 H3 OTHER TEXT : SINGLE-USE, DEVICE DISCARDED.
D4 UDI: (B)(4) THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION OR UPON RECEIPT OF NEW INFORMATION. H3 OTHER TEXT: SINGLE-USE, DEVICE DISCARDED.
THE CONSUMER REPORTED TWO (2) FALSE NEGATIVE RESULTS WITH THE BINAXNOW COVID-19 ANTIGEN SELF TEST FOR TWO TESTS PERFORMED ON (B)(6) 2023 AND (B)(6) 2023. THIS MFR. REPORT ADDRESSES TEST ONE (1) OF TWO (2). ADDITIONAL TESTING WAS PERFORMED (TWICE) ON THE (B)(6) 2023 AND (B)(6) 2023 WITH A NON-ABBOTT TEST (PLATFORM - SIEMENS COVID-19 TEST) WHICH GENERATED A POSITIVE RESULT. REPEAT TESTING WAS PERFORMED ON THE (B)(6) 2023 WHICH GENERATED A POSITIVE RESULT. THE CONSUMER STATED THAT THEY WERE NOT FEELING WELL AND WAS TAKING PAXLOVID PROVIDED BY HIS HEALTHCARE PROVIDER. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CUSTOMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN THE PATIENT'S TREATMENT.
THE CONSUMER REPORTED TWO (2) FALSE NEGATIVE RESULTS WITH THE BINAXNOW COVID-19 ANTIGEN SELF TEST FOR TWO TESTS PERFORMED ON (B)(6) 2023 AND (B)(6) 2023. THIS MFR. REPORT ADDRESSES TEST ONE (1) OF TWO (2). ADDITIONAL TESTING WAS PERFORMED (TWICE) ON THE (B)(6) 2023 AND (B)(6) 2023 WITH A NON-ABBOTT TEST (PLATFORM - SIEMENS COVID-19 TEST) WHICH GENERATED A POSITIVE RESULT. REPEAT TESTING WAS PERFORMED ON THE (B)(6) 2023 WHICH GENERATED A POSITIVE RESULT. THE CONSUMER STATED THAT THEY WERE NOT FEELING WELL AND WAS TAKING PAXLOVID PROVIDED BY HIS HEALTHCARE PROVIDER. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CUSTOMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN THE PATIENT'S TREATMENT.
THE CONSUMER REPORTED TWO (2) FALSE NEGATIVE RESULTS WITH THE BINAXNOW COVID-19 ANTIGEN SELF TEST FOR TWO TESTS PERFORMED ON (B)(6) 2023 AND (B)(6) 2023. THIS MFR. REPORT ADDRESSES TEST ONE (1) OF TWO (2). ADDITIONAL TESTING WAS PERFORMED (TWICE) ON THE (B)(6) 2023 AND (B)(6) 2023 WITH A NON-ABBOTT TEST (PLATFORM - SIEMENS COVID-19 TEST) WHICH GENERATED A POSITIVE RESULT. REPEAT TESTING WAS PERFORMED ON THE (B)(6) 2023 WHICH GENERATED A POSITIVE RESULT. THE CONSUMER STATED THAT THEY WERE NOT FEELING WELL AND WAS TAKING PAXLOVID PROVIDED BY HIS HEALTHCARE PROVIDER. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CUSTOMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN THE PATIENT'S TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2092038 | BINAXNOW COVID-19 AG SELF TEST 2CT | CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | QKP | ABBOTT DIAGNOSTICS SCARBOROUGH, INC. | 203111 | 00811877011408 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Male |