BINAXNOW COVID-19 AG SELF TEST 4CT
Report
- Report Number
- 1221359-2024-00659
- Event Type
- Malfunction
- Date Received
- October 28, 2024
- Date of Event
- October 1, 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
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.
CORRECTED DATA - BECOME AWARE DATE / DATE DUE / G3 - DATE RECEIVED BY MFG / B3 - DATE OF EVENT - THE DATE INDICATED IS AN APPROXIMATION AS THE EXACT EVENT DATE WAS NOT PROVIDED / B5 - DESCRIBE EVENT OR PROBLEM 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.
B3 - DATE OF EVENT - THE DATE INDICATED IS AN APPROXIMATION AS THE EXACT EVENT DATE WAS NOT PROVIDED CORRECTIONS: G3 - DATE RECEIVED BY MFG ON REPORT NUMBER 1221359-2024-00659-00 SHOULD BE 05OCT2024. G3 - DATE RECEIVED BY MFG ON REPORT NUMBER 1221359-2024-00659-01 SHOULD BE 28OCT2024. ATTEMPTS WERE MADE TO OBTAIN LOT INFORMATION FOR THIS EVENT AND WERE UNSUCCESSFUL. THE LOT NUMBER INVOLVED IN THIS EVENT IS UNKNOWN. INFORMATION REMOVED FROM: D4 ¿ LOT NUMBER, D4 ¿ EXPIRATION DATE, D4 ¿ PRIMARY UDI NUMBER, H4 ¿ DEVICE MFG DATE INVESTIGATION RESULTS IN H11 WERE REPLACED (SEE BELOW): THE INTAKE INFORMATION REQUIRED TO ENABLE FURTHER INVESTIGATION, SUCH AS THE KIT¿S LOT NUMBER, WAS NOT PROVIDED AND AN INVESTIGATION WAS NOT ABLE TO BE PERFORMED. NOTWITHSTANDING, COMPLAINTS AGAINST THESE TREND CODES ARE MONITORED TO IDENTIFY AND TRACK ANY OUT-OF-TREND/UNEXPECTED PERFORMANCE AT THE LOT AND PRODUCT FAMILY LEVEL. IN CONCLUSION, ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUES AS NO INFORMATION WAS PROVIDED FOR INVESTIGATION.
THE CONSUMER REPORTED FOUR NEGATIVE RESULTS WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON (B)(6) 2024. THIS MANUFACTURER'S REPORT ADDRESSES TEST FOUR (4) OF FOUR (4), FOR THE WIFE. THE CONSUMER PERFORMED TWO ADDITIONAL BINAXNOW COVID-19 ANTIGEN SELF-TESTS ON UNKNOWN DATES AND GENERATED POSITIVE RESULTS. THE CONSUMER WAS EXPERIENCING SYMPTOMS OF A COUGH, RUNNING NOSE, AND FEELING TIRED. HER DOCTOR MENTIONED THAT SHE NEEDS TO RETAKE THE TEST. 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 2 (QTY 2), TEST (4) OF SIX OF (6). THE CONSUMER WAS EXPERIENCING SYMPTOMS OF A COUGH, RUNNING NOSE, AND FEELING TIRED, AND HER DOCTOR MENTIONED THAT SHE NEEDS TO RETAKE THE TEST. 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 2 (TEST QTY 2), TEST (4) OF SIX OF (6). THE CONSUMER WAS EXPERIENCING SYMPTOMS OF A COUGH, RUNNING NOSE, AND FEELING TIRED, AND HER DOCTOR MENTIONED THAT SHE NEEDS TO RETAKE THE TEST. THE CONSUMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1197084 | 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 | 67 YR | Female |