BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 ANTIGEN SELF TEST

    MDR report key: 15478379 · Received September 24, 2022

    Report

    Report Number
    1221359-2022-04499
    Event Type
    Malfunction
    Date Received
    September 24, 2022
    Date of Event
    September 13, 2022
    Report Date
    September 23, 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

    THIS REPORT IS BEING SUBMITTED TO PROVIDE THE INITIAL REPORT AND INVESTIGATION CONCLUSION. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS (B)(4), INC. ON RETAINED KIT LOT 173451 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 173451 AND DEVICE PART NUMBER 195-430H / LOT 170827. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED ASFALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 173451 SHOWED THAT THE COMPLAINT RATE IS (B)(4). IN CONCLUSION, 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 SPECIFIC PATIENT SAMPLE.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED AN UNCONFIRMED FALSE NEGATIVE RESULTS WITH THE BINAX NOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON (B)(6) 2022. THE CONSUMER PERFORMED AN ALTERNATE TESTING ON (B)(6) 2022 USING AN IHEALTH TEST THAT GENERATED A POSITIVE RESULT. CONFIRMATION TESTING WAS NOT PERFORMED. THE PATIENT WAS SYMPTOMATIC (SLIGHT HEADACHE, FEELING "FIZZY", SORE THROAT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127097 BINAXNOW COVID-19 ANTIGEN SELF TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 173451 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female