BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 12062992 · Received June 24, 2021

    Report

    Report Number
    1221359-2021-01839
    Event Type
    Malfunction
    Date Received
    June 24, 2021
    Report Date
    March 17, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    10811877011269
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    NEW INFORMATION: (D4): ADDED DEVICE LOT NUMBER, UDI NUMBER, AND EXPIRATION DATE. (H4): ADDED MANUFACTURING DATE. INVESTIGATION COMPLETE: H10: THE MANUFACTURING AND QUALITY CONTROL RELEASE TESTING WERE REVIEWED FOR TEST BASE LOT 1021705 AND THEY MET RELEASE SPECIFICATIONS. ADDITIONALLY, THE RETAIN KITS WERE TESTED WITH ABBOTT DIAGNOSTICS SCARBOROUGH'S LIMIT OF DETECTION (LOD) POSITIVE QUALITY CONTROL X2 DEVICES AND NEGATIVE CONTROL SWABS X2 DEVICES. ALL TESTS PERFORMED AS EXPECTED WITH NO FALSE POSITIVE RESULTS OBSERVED. THE CURRENT OVERALL INCIDENT RATE FOR FALSE POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) FOR THIS SPECIFIC LOT BASED ON THE TOTAL QUANTITY OF DEVICES MANUFACTURED FOR DISTRIBUTION IS 0.004%. BASED ON THE EVIDENCE AVAILABLE, IT INDICATES THAT THIS DEVICE LOT IS PERFORMING AS EXPECTED. ADDITIONALLY, THE MANUFACTURING RECORDS AND QUALITY CONTROL RELEASE TESTING WERE REVIEWED FOR KIT PART NUMBER 190-000 / LOT 1021705 AND TEST BASE PART NUMBER 190-430 / LOT 1021705. QUALITY CONTROL RELEASE TESTING MET SPECIFICATIONS WITH NO FALSE POSITIVE RESULTS OBSERVED. ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE AS THE LOGFILES WERE NOT PROVIDED.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. THE INSTRUMENT WAS NOT RETURNED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN UNSPECIFIED AMOUNT OF FALSE POSITIVE RESULTS WHILE USING THE ID NOW COVID-19 ASSAY. RETESTING ON THE SAME DAY AND/OR NO LONGER THAN 24 HOURS LATER (PLATFORM NOT PROVIDED) GENERATED NEGATIVE RESULTS. PER THE CUSTOMER THE PATIENTS ARE ASYMPTOMATIC AND HAVE BEEN PREVIOUSLY VACCINATED. ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    953579 ID NOW COVID-19 ASSAY IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1021705 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown