BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST

    MDR report key: 12178177 · Received July 15, 2021

    Report

    Report Number
    1221359-2021-01949
    Event Type
    Malfunction
    Date Received
    July 15, 2021
    Date of Event
    June 17, 2021
    Report Date
    November 28, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS 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

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

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE CORRECTED DATA.

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS (B)(4), INC. ON RETAINED KIT LOT 154389 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 154389, TEST BASE PART NUMBER 195-430H / LOT 151075. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 154389 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS (B)(4) WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE; HOWEVER, IT COULD POSSIBLY BE RELATED TO THE SPECIFIC PATIENT SAMPLE.

    Description of Event or Problem · 0

    THE PARENT REPORTED A FALSE POSITIVE RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON (B)(6) 2021 ON A NASAL SWAB. ANTIGEN TEST ON (B)(6) 2021 AND RAPID DIAGNOSTIC TEST AT DAYCARE CENTER ON (B)(6) 2021 WAS PERFORMED AND GENERATED NEGATIVE RESULTS RESPECTIVELY. PCR CONFIRMATION TESTING GENERATED NEGATIVE RESULT (PLATFORM UNKNOWN). THE PARENT STATED THE PATIENT WAS SYMPTOMATIC AND EXPERIENCED COUGH, RUNNY NOSE ON (B)(6) 2021 AND FELT LIKE NOT EATING ANYTHING ON (B)(6) 2021 . HEALTHCARE PROVIDER PRESCRIBED ALLEGRA MEDICATION AFTER PATIENT TESTED NEGATIVE WITH ANTIGEN TEST ON (B)(6) 2021. ADDITIONALLY, PARENT STATED THAT MEDICATION PRESCRIBED TO PATIENT DID NOT WORKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1073098 BINAXNOW COVID-19 AG SELF TEST LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 154389 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 Male