BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 ANTIGEN SELF-TEST

    MDR report key: 15496207 · Received September 28, 2022

    Report

    Report Number
    1221359-2022-04806
    Event Type
    Malfunction
    Date Received
    September 28, 2022
    Date of Event
    September 6, 2022
    Report Date
    September 27, 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

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS (B)(4), INC. ON RETAINED KIT LOT 207193 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 207193, TEST BASE PART NUMBER 195-430H / LOT 203399. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE NEGATIVE (CONFIRMED, UNCONFIRMED AND CONFLICTING RESULTS) RELATED TO KIT LOT 207193 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS (B)(4) 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.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON (B)(6) 2022. CONFIRMATION PCR TESTING WAS PERFORMED AT A LABORATORY THAT GENERATED A POSITIVE RESULT ON (B)(6) 2022. THE CUSTOMER STATED SHE WAS SYMPTOMATIC AS OF (B)(6) 2022 AND PLACED ON MEDICATION AFTER RECEIVING THE PCR TEST RESULT. THE CUSTOMER CONFIRMED THERE WAS NO SERIOUS INJURY BASED ON THE TEST RESULT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1886025 BINAXNOW COVID-19 ANTIGEN SELF-TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 207193 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female Congenital Anomaly