BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW¿ COVID-19 ANTIGEN SELF TEST

    MDR report key: 12346195 · Received August 19, 2021

    Report

    Report Number
    1221359-2021-02344
    Event Type
    Malfunction
    Date Received
    August 19, 2021
    Date of Event
    July 26, 2021
    Report Date
    November 28, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QKP
    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 SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE CORRECTED DATA AND ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    H10: TESTING WAS PERFORMED ON RETAIN KIT LOT 153354 WITH THE ABBOTT DIAGNOSTICS SCARBOROUGH'S LIMIT OF DETECTION (LOD) POSITIVE QUALITY CONTROL X3 DEVICES AND NEGATIVE (BLANK) SWABS X3 DEVICES. ALL TEST RESULTS WERE VALID AND PERFORMED AS EXPECTED. ADDITIONALLY, THE MANUFACTURING AND QUALITY CONTROL RELEASE TESTING WERE REVIEWED FOR KIT PART NUMBER 195-160 / LOT 153354 AND TEST DEVICE 195-430H / LOT 148399 AND THEY MET RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 153476 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 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 OR THE SPECIFIC PATIENT SAMPLE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CONSUMER REPORTED A FALSE POSITIVE RESULT WITH THE BINAXNOW¿ COVID-19 ANTIGEN SELF TEST PERFORMED ON (B)(6) 2021 ON A NASAL SWAB. REPEAT TESTING WAS PERFORMED AND GENERATED A POSITIVE RESULT. THE CONSUMER STATED SHE WAS FULLY VACCINATED. THE CONSUMER CONFIRMED SHE WAS SYMPTOMATIC AND EXPERIENCING CONGESTION & SORE THROAT. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1243044 BINAXNOW¿ COVID-19 ANTIGEN SELF TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 153354

    Patients

    Seq Age Sex Outcome Treatment
    1 Female