BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAX NOW COVID-19 AG CARD

    MDR report key: 12251825 · Received July 30, 2021

    Report

    Report Number
    1221359-2021-02147
    Event Type
    Malfunction
    Date Received
    July 30, 2021
    Date of Event
    July 8, 2021
    Report Date
    January 30, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QKP
    PMA / PMN Number
    EUA202537
    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

    INVESTIGATION: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 153679 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 &195-263 / LOT 153679 AND DEVICE PART NUMBER 195-230WL & 195-430WL / LOT 149491. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS CONFLICTING RESULTS PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 153679 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE HOWEVER A POSSIBLE ASSIGNABLE ROOT CAUSE IS RELATED TO ISSUES INCLUDING THE SELF-TEST USER PERFORMANCE OR THE SPECIFIC PATIENT SAMPLE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A CONFLICTING RESULT WITH THE BINAX NOW COVID-19 AG CARD ASSAY PERFORMED ON (B)(6) 2021. THE CUSTOMER REPORTED SHE COULD SEE A PINK LINE ON THE CONTROL LINE AND A HORIZONTAL LINE ON THE VERY RIGHT SIDE, AND THERE'S NO LINE ON THE SAMPLE LINE. THE CUSTOMER STATED SHE RECEIVED A POSITIVE RESULT ON THE FIRST TEST AND A NEGATIVE RESULT ON THE SECOND TEST ( DATE AND TIME NOT PROVIDED FOR THE SECOND TEST). ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1150141 BINAX NOW COVID-19 AG CARD LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 153679

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown