BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID 19 AG SELF TEST

    MDR report key: 14118327 · Received April 15, 2022

    Report

    Report Number
    1221359-2022-02202
    Event Type
    Malfunction
    Date Received
    April 15, 2022
    Report Date
    April 28, 2022
    Manufacturer
    ABBOTT DIAGNOSTIC 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

    THIS INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 178037 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 195-160/195-260 / LOT 178037 AND DEVICE PART NUMBER 195-430WL / LOT 174904. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS CONFLICTING RESULTS PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 178037 SHOWED THAT THE COMPLAINT RATE IS (B)(4). IN ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE HOWEVER A POSSIBLE ASSIGNABLE ROOT CAUSE IS 178037.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A CONFLICTING RESULTS RESULT WITH THE BINAXNOW COVID 19 AG SELF TEST (195-160) . THE CUSTOMER INFORMED THAT SHE TOOK A FIRST TEST AND IT CAME OUT POSITIVE AND THE SECOND TEST CAME OUT NEGATIVE NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2174077 BINAXNOW COVID 19 AG SELF TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP ABBOTT DIAGNOSTIC SCARBOROUGH, INC 178037 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 Female