BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BINAXNOW COVID-19 AG SELF TEST

    MDR report key: 12333018 · Received August 17, 2021

    Report

    Report Number
    1221359-2021-02308
    Event Type
    Injury
    Date Received
    August 17, 2021
    Date of Event
    July 19, 2021
    Report Date
    November 30, 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
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT: 153364 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: 153364, TEST BASE PART NUMBER: 195-430H /148134 LOT. 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: 153364 SHOWED THAT THE COMPLAINT (B)(4). A REVIEW OF THE COMPLAINTS REPORTED AS FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT: 153364 SHOWED THAT THE COMPLAINT (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE [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 CONFLICTING RESULTS WITH THE BINAXNOW AG SELF TEST PERFORMED (B)(6) 2021 THAT GENERATED NEGATIVE RESULTS. REPEAT TESTING WAS PERFORMED THE SAME DAY AND GENERATED POSITIVE RESULTS.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Description of Event or Problem · 1

    THE CONSUMER REPORTED AN CONFLICTING RESULTS WITH THE BINAXNOW AG SELF TEST PERFORMED ON (B)(6) 2021, THIS GENERATED NEGATIVE RESULTS. REPEAT TESTING WAS PERFORMED ON (B)(6) 2021 AND GENERATED POSITIVE RESULTS. PER THE CONSUMER, THE PATIENT WAS SYMPTOMATIC WITH COUGH, FEVER, SHORTNESS OF BREATH, AND BODY PAINS. NO ADDITIONAL INFORMATION, INCLUDING PATIENT TREATMENT AND OUTCOMEW AS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1227663 BINAXNOW COVID-19 AG SELF TEST LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 153364 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 Female