BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW¿ COVID-19 ANTIGEN SELF TEST

    MDR report key: 12071635 · Received June 25, 2021

    Report

    Report Number
    1221359-2021-01830
    Event Type
    Malfunction
    Date Received
    June 25, 2021
    Date of Event
    May 23, 2021
    Report Date
    June 10, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCABOROUGH
    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

    CORRECTIONS: D3, G1, G4 (PMA/510(K)). INVESTIGATION REPORT: TESTING WAS PERFORMED IN TRIPLICATE AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 153476 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 KIT PART NUMBER 195-160 / LOT 153476 AND DEVICE PART NUMBER 195-430H / LOT 148405. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. THE CURRENT OVERALL INCIDENT RATE FOR RESULTS COMPLAINTS FOR THIS SPECIFIC LOT BASED ON THE TOTAL DISTRIBUTED DEVICES IS (B)(4). NO ADDITIONAL INVESTIGATION IS NECESSARY AS A PRODUCT DEFICIENCY WAS NOT IDENTIFIED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION NOT YET COMPLETE. UPON COMPLETION, THE INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    THE USER REPORTED DIFFERENT RESULTS ON DIRECT TESTED NASAL KITTED SWABS WITH THE BINAXNOW¿ COVID-19 ANTIGEN SELF TEST AND UNSPECIFIED ANTIGEN TESTS PERFORMED ON VARIOUS DATES. BASED ON THE INFORMATION PROVIDED, THE INITIAL TEST (BINAXNOW¿ COVID-19 ANTIGEN SELF TEST) PERFORMED ON (B)(6) 2021 GENERATED POSITIVE RESULTS. ADDITIONAL TESTING ON (B)(6) 2021 USING THE BINAXNOW¿ COVID-19 ANTIGEN SELF TEST GENERATED NEGATIVE RESULTS. TESTING (UNSPECIFIED ANTIGEN) PERFORMED ON (B)(6) 2021 GENERATED POSITIVE RESULTS. THE USER STATES THAT HE HAD AN ADDITIONAL TEST USING THE BINAXNOW¿ COVID-19 ANTIGEN SELF TEST THAT GENERATING NEGATIVE RESULTS. PER THE USER, HE WAS NOT SYMPTOMATIC. THE USER STATED HE ISOLATED FOR 10 DAYS AND THERE WAS NO TREATMENT AS HE JUST DRANK ZINC, VITAMIN C, AND ATE FRUITS AND VEGETABLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    965327 BINAXNOW¿ COVID-19 ANTIGEN SELF TEST LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCABOROUGH 153476 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 Male