BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAX NOW COVID-19 AG CARD

    MDR report key: 12513227 · Received September 22, 2021

    Report

    Report Number
    1221359-2021-02704
    Event Type
    Malfunction
    Date Received
    September 22, 2021
    Date of Event
    June 24, 2021
    Report Date
    April 28, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QKP
    UDI-DI
    10811877011290
    PMA / PMN Number
    EUA202537
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 132164 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 195-000 LOT 132164,TEST BASE PART NUMBER 195-430H / LOT 129781A.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 132164 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 THE SPECIFIC PATIENT SAMPLES.

    Additional Manufacturer Narrative · 0

    THIS INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE PROVIDED. (B)(6). REFERENCE MFR. REPORT: 1221359-2021-02705, 1221359-2021-02706, 1221359-2021-02707, 1221359-2021-02708, 1221359-2021-02709, 1221359-2021-02710.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSE NEGATIVE RESULTS WITH THE BINAX NOW COVID-19 AG CARD ASSAY FOR MULTIPLE PATIENTS PERFORMED ON MULTIPLE DATES. THIS MFR. REPORT ADDRESSES PATIENT (1) ONE OF (7) SEVEN. THE CUSTOMER REPORTED FALSE NEGATIVE RESULT ON A DIRECT TESTED NASAL KITTED SWAB WITH THE BINAXNOW COVID-29 AG CARD ASSAY PERFORMED ON (B)(6) 2021. CONFIRMATION TESTING WAS PERFORMED WITH PCR AND GENERATED POSITIVE RESULTS (CT VALUES NOT PROVIDED). PER THE CUSTOMER, THE PATIENT WAS SYMPTOMATIC. ADDITIONALLY, THERE WAS NO INJURIES DUE TO TEST RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1411563 BINAX NOW COVID-19 AG CARD LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 132164 10811877011290

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female