BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 SELF-TEST

    MDR report key: 13668483 · Received March 4, 2022

    Report

    Report Number
    1221359-2022-00790
    Event Type
    Malfunction
    Date Received
    March 4, 2022
    Date of Event
    February 9, 2022
    Report Date
    June 7, 2022
    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

    Additional Manufacturer Narrative · 0

    THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE INVESTIGATION CONCLUSION. PLEASE SEE UPDATE: G3, G6, H2 AND H6. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 180390 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 195-160/ LOT 180390 AND DEVICE PART NUMBER 195-430H / LOT 173418. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. THE CURRENT OVERALL INCIDENT RATE FOR FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) FOR THIS SPECIFIC LOT BASED ON THE TOTAL QUANTITY OF DEVICES MANUFACTURED FOR DISTRIBUTION IS 0.0006%. ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE AN ASSIGNABLE ROOT CAUSE, HOWEVER, IT COULD POSSIBLY BE RELATED TO ISSUES INCLUDING THE SELF-TEST USER PERFORMANCE, INTERPRETATION OF THE RESULT, OR THE SPECIFIC PATIENT SAMPLE.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 SELF-TEST PERFORMED ON (B)(6) 2022. CONFIRMATION TESTING (VIA RT-PCR) 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
    1962818 BINAXNOW COVID-19 SELF-TEST LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 180390 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown