BINAXNOW COVID-19 AG SELF TEST 2CT
Report
- Report Number
- 1221359-2023-01565
- Event Type
- Malfunction
- Date Received
- October 20, 2023
- Date of Event
- October 4, 2023
- Report Date
- November 21, 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
D4: UDI (B)(4). TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 221038 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 KIT PART NUMBER 195-160 / LOT 221038 AND DEVICE PART NUMBER 195-430H / LOT 217299. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. THE CURRENT OVERALL INCIDENT RATE FOR FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) FOR LOT 221038 BASED ON THE TOTAL QUANTITY OF DEVICES DISTRIBUTED IS (B)(4). IN CONCLUSION, 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.G3 DATE RECEIVED BY MFG. 08NOV2023 H3 OTHER TEXT : OTHER - DEVICE NOT RETURNED; SINGLE USE DEVICE.
D4: (B)(4). THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. H3 OTHER TEXT: OTHER - DEVICE NOT RETURNED; SINGLE USE DEVICE.
D4: UDI (B)(4). THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.B3; B5; E1 - COUNTRY. OTHER - DEVICE NOT RETURNED; SINGLE USE DEVICE.
THE CONSUMER REPORTED EIGHT (8) FALSE NEGATIVE RESULTS AMONG THREE (3) CONSUMERS WITH THE BINAXNOW COVID-19 SELF-TEST PERFORMED ON VARIOUS DATES. THIS MFR. REPORT ADDRESSES TEST ONE (1) OF EIGHT (8); CONSUMER ONE (1) OF THREE (3). THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 SELF-TEST PERFORMED ON (B)(6) 2023 ON A NASAL SWAB. ADDITIONAL TESTING WAS PERFORMED WITH A QUICKVIEW ANTIGEN TEST GENERATING A POSITIVE RESULT ON AN UNKNOWN DATE. THE CONSUMER CONFIRMED THERE WAS NO HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CONSUMER CONFIRMED THERE WAS NO DELAY OR IMPACT TO THEIR TREATMENT.
THE CONSUMER REPORTED TWO FALSE NEGATIVE RESULTS ON A BINAXNOW COVID-19 SELF-TEST PERFORMED ON (B)(6) 2023 USING A NASAL SWAB. THIS REPORT IS FOR TEST ONE (1) OF TWO (2). PREVIOUS TESTING WAS PERFORMED TWICE ON (B)(6) 2023 USING AN UNKNOWN ANTIGEN TEST GENERATING TWO POSITIVE RESULTS. THE CONSUMER CONFIRMED THERE WAS NO HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CONSUMER CONFIRMED THERE WAS NO DELAY OR IMPACT TO THEIR TREATMENT.
THE CONSUMER REPORTED EIGHT (8) FALSE NEGATIVE RESULTS AMONG THREE (3) CONSUMERS WITH THE BINAXNOW COVID-19 SELF-TEST PERFORMED ON VARIOUS DATES. THIS MFR. REPORT ADDRESSES TEST ONE (1) OF EIGHT (8); CONSUMER ONE (1) OF THREE (3). THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 SELF-TEST PERFORMED ON (B)(6) 2023 ON A NASAL SWAB. ADDITIONAL TESTING WAS PERFORMED WITH A QUICKVIEW ANTIGEN TEST GENERATING A POSITIVE RESULT ON AN UNKNOWN DATE. THE CONSUMER CONFIRMED THERE WAS NO HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CONSUMER CONFIRMED THERE WAS NO DELAY OR IMPACT TO THEIR TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1121804 | BINAXNOW COVID-19 AG SELF TEST 2CT | CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | QKP | ABBOTT DIAGNOSTICS SCARBOROUGH, INC. | 221038 | 00811877011408 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Female |