BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST OTC

    MDR report key: 14593770 · Received June 3, 2022

    Report

    Report Number
    1221359-2022-02681
    Event Type
    Malfunction
    Date Received
    June 3, 2022
    Date of Event
    May 1, 2022
    Report Date
    June 3, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QKP
    UDI-DI
    00811877011408
    PMA / PMN Number
    EUA210264
    Adverse Event
    Yes
    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 195563 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 195563 AND DEVICE PART NUMBER 195-430H / LOT 191831. 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 144396 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 SELF-TEST USER PERFORMANCE, INTERPRETATION OF THE RESULT, OR THE SPECIFIC PATIENT SAMPLE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TWO FALSE POSITIVE RESULTS WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST OTC PERFORMED ON (B)(6) 2022 AND (B)(6) 2022. THIS MFR. REPORT ADDRESSES 1 OF 2 TEST RESULTS. THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST OTC ASSAY PERFORMED ON (B)(6) 2022 ON A DIRECT TESTED NASAL KITTED SWAB. THE CUSTOMER REPORTED THAT THERE WAS NO BLOOD ON SWAB AND NO NASAL SPRAY WAS USED PRIOR TO TESTING. REPEAT TESTING WAS PERFORMED ON (B)(6) 2022 WITH A BINAXNOW COVID-19 ANTIGEN SELF-TEST OTC AND GENERATED A POSITIVE RESULT. ON (B)(6) 2022 A ROCHE ANTIGEN TEST WAS ALSO PERFORMED AND GENERATED A POSITIVE RESULT. PCR CONFIRMATION TESTING WAS PERFORMED ON (B)(6) 2022 AND RESULTS PROVIDED ON (B)(6) 2022 DISPLAYED A NEGATIVE RESULT (CT VALUES NOT PROVIDED). A THIRD PCR TEST PERFORMED ON (B)(6) 2022, CAME BACK (B)(6) 2022 WITH POSITIVE RESULTS. THE CUSTOMER STATED THE PATIENT WAS EXPERIENCING A SLOWING IN HEART RATE. THE PATIENT WENT TO URGENT CARE WHERE AN EKG WAS PERFORMED. THE CUSTOMER REPORTED THAT IT COULD NOT BE DETERMINED WHETHER THIS WAS RELATED TO COVID-19. AFTER CONSULTING CARDIOLOGIST, THE RECOMMENDATION WAS TO GO TO THE HOSPITAL. IN ADDITION, THE PATIENT WAS PRESCRIBED MOLNUPIRAVIR, ANTI-VIRAL MEDICATION GIVEN TO PATIENTS WHO TEST POSITIVE ON (B)(6) 2022. REQUIRED TO TAKE DAILY FOR FIVE (5) DAYS. THE PATIENT WENT TO THE EMERGENCY ROOM BUT WAS NOT ADMITTED. THE PATIENT WAS RELEASED AFTER 3-4 HOURS AFTER MONITORING AND CHEST X-RAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2035238 BINAXNOW COVID-19 AG SELF TEST OTC LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 195563 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Hospitalization