BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAX NOW COVID-19 AG CARD

    MDR report key: 12286011 · Received August 6, 2021

    Report

    Report Number
    1221359-2021-02225
    Event Type
    Malfunction
    Date Received
    August 6, 2021
    Date of Event
    July 12, 2021
    Report Date
    August 5, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QKP
    PMA / PMN Number
    EUA202537
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. PLEASE SEE MFR. REPORT # 1221359-2021-02225.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE BINAXNOW COVID-19 ANTIGEN TEST PERFORMED ON (B)(6) 2021 ON A TESTED MID-NASAL KITTED SWAB USING TWO DIFFERENT LOTS. THIS MFR. REPORT ADDRESSES LOT 2 OF 2. THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THEBINAXNOW COVID-19 ANTIGEN TEST PERFORMED (B)(6) 2021 ON A TESTED MIDNASAL SWAB AND GENERATED POSITIVE RESULTS. ON THE SAME DAY REPEAT TESTING WAS PERFORMED WITH A NEW BINAXNOW CARD AND WITH A NEW SAMPLE AND AGAIN GENERATED NEGATIVE RESULTS. THE CUSTOMER REPORTED PCR CONFIRMATION TESTING WAS PERFORMED (B)(6) 2021 ON A NASOPHARYNGEAL SWAB AND GENERATED NEGATIVE RESULTS. THE CUSTOMER REPORTED THAT THE PATIENT TOOK A TOTAL OF (4) BINAXNOW COVID-19 ANTIGEN TEST, (3) USING LOT # 153364 AND (1) USING LOT # 154389. THE CUSTOMER STATED THE PATIENT WAS NOT SYMPTOMATIC AND THE PATIENT WAS VACCINATED (PFIZER). THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CUSTOMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN THE PATIENT'S TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1186342 BINAX NOW COVID-19 AG CARD LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 154389

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR