BINAXNOW COVID-19 ANTIGEN SELF-TEST
Report
- Report Number
- 1221359-2022-00792
- Event Type
- Malfunction
- Date Received
- February 14, 2022
- Date of Event
- January 31, 2022
- Report Date
- June 16, 2022
- Manufacturer
- ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
- Product Code
- QKP
- PMA / PMN Number
- EUA210264
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.
THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.
INVESTIGATION REPORT: TESTING WAS PERFORMED IN TRIPLICATE AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 173444 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 KIT PART NUMBER 195-160/ LOT 173444 AND DEVICE PART NUMBER 195-430H / LOT 170764. 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 173444 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 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. REFERENCE MFR. REPORTS: (B)(4)AND (B)(4).
REFERENCE MFR. REPORTS: 1221359-2022-01061 AND 1221359-2022-01062.
THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF TEST PERFORMED ON (B)(6) 2022. REPEAT TESTING WAS PERFORMED ON (B)(6) 2022 AT A PHYSICIANS OFFICE AND GENERATED A POSITIVE RESULT. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.
THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF TEST PERFORMED ON (B)(6) 2022. REPEAT TESTING WAS PERFORMED ON (B)(6) 2022 AT A PHYSICIANS OFFICE AND GENERATED A POSITIVE RESULT. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.
THE CUSTOMER REPORTED FALSE NEGATIVE RESULTS WITH THE BINAXNOW COVID-19 ANTIGEN SELF TEST FOR MULTIPLE TESTS PERFORMED ON (B)(6) 2022. THIS MFR. REPORT ADDRESSES TEST 1 OF 3. REPEAT TESTING WAS PERFORMED TWICE AND GENERATED NEGATIVE RESULTS. CONFIRMATION TESTING VIA AN UNKNOWN PLATFORM WAS PERFORMED AT A PHYSICIAN'S OFFICE AND GENERATED A POSITIVE RESULT. THE CUSTOMER STATED THE PATIENT WAS SYMPTOMATIC. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 557830 | BINAXNOW COVID-19 ANTIGEN SELF-TEST | LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 | QKP | ABBOTT DIAGNOSTICS SCARBOROUGH, INC. | 173444 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 5 YR | Male |