BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG CARD

    MDR report key: 12604633 · Received October 11, 2021

    Report

    Report Number
    1221359-2021-03113
    Event Type
    Malfunction
    Date Received
    October 11, 2021
    Date of Event
    September 14, 2021
    Report Date
    April 26, 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
    MO, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 133366 WITH COVID-19 LOD AND BLANK PATIENT SWABS. ALL TEST RESULTS WERE VALID AND PERFORMED AS EXPECTED. ADDITIONALLY, THE MANUFACTURING RECORDS AND QUALITY CONTROL RELEASE TESTING WAS REVIEWED FOR KIT PART NUMBER 195-000/ LOT 133366 AND DEVICE PART NUMBER 195-430H / LOT 131340A. 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 133366 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/VALIDATION SAMPLES.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 AG CARD PERFORMED ON (B)(6) 2021 ON A DIRECT TESTED NASAL KITTED SWAB. REPEAT TESTING WAS PERFORMED. RESULTS USING BINAXNOW COVID-19 AG CARD ON (B)(6) 2021 AND (B)(6) 2021 WERE NEGATIVE. PCR CONFIRMATION TESTING ON (B)(6) 2021 ON NASAL SWAB WITH GENERATED POSITIVE RESULTS (CT VALUES NOT PROVIDED). THE CUSTOMER STATED THE PATIENT WAS SYMPTOMATIC. 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
    1507271 BINAXNOW COVID-19 AG CARD LATERAL FLOW IMMUNOASSAY IVD COVID-19 QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 133366 10811877011290

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Female