BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG CARD

    MDR report key: 13685199 · Received March 7, 2022

    Report

    Report Number
    1221359-2022-01329
    Event Type
    Malfunction
    Date Received
    March 7, 2022
    Date of Event
    August 6, 2021
    Report Date
    December 12, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QKP
    UDI-DI
    00811877011293
    PMA / PMN Number
    EUA202537
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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. RELATED MFR REPORT NUMBERS: 1221539-2021-02584 AND 1221359-2022-01328 THROUGH 1221359-2022-01334.

    Additional Manufacturer Narrative · 0

    INVESTIGATION REPORT: TESTING WAS PERFORMED IN AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 151093 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 151093, TEST DEVICE PART NUMBER 195-430 / LOT 145158A. 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 151093 SHOWED THAT THE COMPLAINT RATE IS 0.003 %. ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE.

    Additional Manufacturer Narrative · 0

    THE SUPPLEMENTAL REPORT IS BEING SUBMITTED TO CORRECT THE PREVIOUSLY REPORTED EVENT AND PROVIDE ADDITIONAL INFORMATION. PLEASE SEE UPDATES: D1, D2, G3, G6 AND H2.

    Description of Event or Problem · 0

    CUSTOMER REPORTED EIGHT FALSE NEGATIVE RESULTS WITH THE BINAXNOW COVID-19 AG CARD ON VARIOUS DATES WITH THE SAME LOT NUMBER. THIS REPORT IS THREE (3) OF EIGHT (8). PATIENT TESTED NEGATIVE WITH THE BINAXNOW COVID-19 AG CARD ON (B)(6) 2021. THE PATIENT HAD FOLLOW-UP TESTING PERFORMED WITH AN ID NOW ON (B)(6) 2021 ON A NASAL SAMPLE WHICH PRESENTED A POSITIVE RESULT. CUSTOMER REPORTED THAT THE PATIENT'S X-RAY PRESENTED "CRACKLES RIGHT LOWER LUNG ZONE, NORMAL CHEST". PATIENT WAS SENT TO THE ER FOR MONOCLONAL ANTIBODIES ON (B)(6) 2021 AND WAS SUBSEQUENTLY DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1337458 BINAXNOW COVID-19 AG CARD CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 151093 00811877011293

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female