BINAXNOW COVID-19 AG SELF TEST 2CT
Report
- Report Number
- 1221359-2022-10073
- Event Type
- Malfunction
- Date Received
- November 8, 2022
- Date of Event
- October 18, 2022
- Report Date
- January 27, 2023
- 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
THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. DEVICE DISCARDED, SINGLE USE.
ADDITIONAL DATA: H10: LOT NUMBERS (202865 AND 210543). LOT NUMBER (202865) EXPIRATION DATE: 07/15/2023 LOT NUMBER (202865) TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 202865 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 202865, TEST BASE PART NUMBER 195-430H / LOT 197969. 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 202865 SHOWED THAT THE COMPLAINT RATE IS (B)(4).. LOT NUMBER (210543) TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 210543 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 210543, TEST BASE PART NUMBER 195-430WL / LOT 207460. 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 210543 SHOWED THAT THE COMPLAINT RATE IS(B)(4).. ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE FALSE NEGATIVE RESULTS HOWEVER, IT COULD POSSIBLY BE RELATED TO ISSUES INCLUDING THE SELF-TEST USER PERFORMANCE, INTERPRETATION OF THE RESULT, OR THE SPECIFIC PATIENT SAMPLE. BASED ON THE ABOVE SUMMARY, THE INVESTIGATION IS DEEMED COMPLETE. ABBOTT DIAGNOSTICS SCARBOROUGH WILL CONTINUE TO MONITOR AND TREND FOR THIS REPORTED ISSUE. H3 OTHER TEXT : DEVICE DISCARDED, SINGLE USE.
TWO LOT NUMBERS WERE USED BY THE CUSTOMER ON DIFFERENT DATES; HOWEVER, THE CUSTOMER WAS NOT ABLE TO IDENTIFY WHICH LOT NUMBER WAS USED ON SPECIFIC DATES.D4 H3 OTHER TEXT : DEVICE DISCARDED, SINGLE USE.
THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH BINAXNOW COVID-19 AG SELF-TEST ON (B)(6) 2022. THE CONSUMER RECEIVED A NEGATIVE RESULT ON BINAXNOW COVID-19 AG, AND A PCR TEST WAS PERFORMED ON (B)(6) 2022, AND GENERATED A POSITIVE RESULT. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.
THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH BINAXNOW COVID-19 AG SELF-TEST ON (B)(6)2022. THE CONSUMER RECEIVED A NEGATIVE RESULT ON BINAXNOW COVID-19 AG, AND A PCR TEST WAS PERFORMED ON (B)(6)2022, AND GENERATED A POSITIVE RESULT. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.
THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH BINAXNOW COVID-19 AG SELF-TEST ON (B)(6) 2022. THE CONSUMER RECEIVED A NEGATIVE RESULT ON BINAXNOW COVID-19 AG, AND A PCR TEST WAS PERFORMED ON (B)(6) 2022, AND GENERATED A POSITIVE RESULT. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2251941 | BINAXNOW COVID-19 AG SELF TEST 2CT | CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | QKP | ABBOTT DIAGNOSTICS SCARBOROUGH, INC. | 210543 | 00811877011408 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |