BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW

    MDR report key: 14956960 · Received July 7, 2022

    Report

    Report Number
    MW5110740
    Event Type
    Malfunction
    Date Received
    July 7, 2022
    Date of Event
    July 5, 2022
    Report Date
    July 5, 2022
    Manufacturer
    ABBOTT
    Product Code
    QKP
    UDI-DI
    00811877011408
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I ATTEMPTED TO TEST FOR COVID WITH A BINAXNOW ANTIGEN SELF TEST. THE TWO REAGENT BOTTLES THAT WERE SUPPOSED TO BE INCLUDED IN THE BOX WERE MISSING AND I CANNOT SELF-TEST. LOT #200627, EXPIRY 7/2/2023. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2060958 BINAXNOW CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP ABBOTT 195-160 200627 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 Female