BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAX NOW COVID-19 AG CARD

    MDR report key: 11657452 · Received April 13, 2021

    Report

    Report Number
    1221359-2021-00964
    Event Type
    Malfunction
    Date Received
    April 13, 2021
    Date of Event
    March 15, 2021
    Report Date
    June 16, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QKP
    UDI-DI
    10811877011290
    PMA / PMN Number
    EUA202537
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: H10: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 133347 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 195-000 / LOT: 133347, TEST BASE PART NUMBER 195-430H / LOT: 130040. 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 133347 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 THE SPECIFIC PATIENT SAMPLES.

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED 6 CONFLICTING RESULTS USING THE BINAX NOW COVID-19 AG CARD PERFORMED ON (B)(6) 2021. THE CUSTOMER CONFIRMED THE PATIENTS WERE ASYMPTOMATIC. REPEAT TESTING WITH A DIFFERENT KIT, SAME LOT NUMBER GENERATED NEGATIVE RESULTS. THE CUSTOMER CONSIDERED THE FALSE POSITIVE RESULTS TO BE FALSE. TWO OF THE PATIENTS ARE FULLY VACCINATED. CONFLICTING RESULTS INDICATE A MALFUNCTION OF ONE OF THE TESTS AS IT IS EXPECTED THAT TESTING THE SAME PATIENT SAMPLE OR A SECOND SAMPLE FROM THE SAME PATIENT TESTED ON THE SAME DAY AS THE ORIGINAL SAMPLE WOULD RETURN THE SAME RESULT. UNEXPLAINED CONFLICTING RESULTS SHALL BE REPORTED AS IT IS UNKNOWN WHICH RESULT IS CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555866 BINAX NOW COVID-19 AG CARD LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 133347 10811877011290

    Patients

    Seq Age Sex Outcome Treatment
    1