BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 2CT

    MDR report key: 19407985 · Received May 28, 2024

    Report

    Report Number
    1221359-2024-00401
    Event Type
    Malfunction
    Date Received
    May 28, 2024
    Date of Event
    May 13, 2024
    Report Date
    June 14, 2024
    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

    Additional Manufacturer Narrative · 0

    SECTION D: IT IS UNCLEAR WHICH LOT OCCURRED WITH THE FALSE POSITIVE BINAXNOW COVID-19 AG SELF TEST RESULT. D4: LOT:224986 EXPIRATION DATE:8/23/2024 UDI:(B)(4) THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Additional Manufacturer Narrative · 0

    SECTION D: IT IS UNCLEAR IF 224986 IS THE ALLEGED LOT THE FALSE POSITIVE BINAXNOW COVID-19 AG SELF TEST RESULT OCCURRED ON. D4: LOT:224986 EXPIRATION DATE:8/23/2024 UDI: (B)(4) LOT 224986 INVESTIGATION: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 224986 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: 224986, TEST BASE PART NUMBER 195-430H/ LOT: 221817. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 224986 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 HAVE POSSIBLY BEEN RELATED TO THE SPECIFIC PATIENT SAMPLE. UNKNOWN LOT INVESTIGATION: THE REQUIRED INTAKE INFORMATION 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.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED A FALSE POSITIVE RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON (B)(6) 2024 ON AN UNKNOWN SAMPLE TYPE. REPEAT TESTING WAS PERFORMED ON THE NEXT DAY, (B)(6) 2024, WHICH GENERATED A NEGATIVE RESULT. ADDITIONAL TESTING WAS PERFORMED ON AN UNKNOWN DATE VIA AN UNKNOWN BRAND ANTIGEN TEST WHICH GENERATED A NEGATIVE RESULT. NO ADDITIONAL INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED A FALSE POSITIVE RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON (B)(6) 2024 ON AN UNKNOWN SAMPLE TYPE. REPEAT TESTING WAS PERFORMED ON THE NEXT DAY, ON (B)(6) 2024, WHICH GENERATED A NEGATIVE RESULT. ADDITIONAL TESTING WAS PERFORMED ON AN UNKNOWN DATE VIA AN UNKNOWN BRAND ANTIGEN TEST WHICH GENERATED A NEGATIVE RESULT. NO ADDITIONAL INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1399036 BINAXNOW COVID-19 AG SELF TEST 2CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female