BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAX NOW COVID-19 AG CARD

    MDR report key: 12868985 · Received November 24, 2021

    Report

    Report Number
    1221359-2021-03556
    Event Type
    Malfunction
    Date Received
    November 24, 2021
    Date of Event
    October 25, 2021
    Report Date
    April 12, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QKP
    UDI-DI
    00811877011408
    PMA / PMN Number
    EUA202537
    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 160348 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 160348 AND TEST BASE PART NUMBER 195-430H / LOT 150409. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 160348 SHOWED THAT THE COMPLAINT RATE IS (B)(4). IN CONCLUSION, ABBOTT DIAGNOSTICS SCARBOROUGH 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.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    THE USER REPORTED A FALSE NEGATIVE WITH THE BINAXNOW¿ COVID-19 ANTIGEN SELF TEST PERFORMED (B)(6) 2021 ON AN UNKNOWN SAMPLE AND GENERATED A NEGATIVE RESULT. THE CUSTOMER REPORTED THEY DECIDED TO PERFORM A PCR TEST AT A LABORATORY NEAR BY. THE RESULTS FROM THE LABORATORY CAME OUT POSITIVE. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1769536 BINAX NOW COVID-19 AG CARD CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 160348 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown