BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 12698416 · Received October 26, 2021

    Report

    Report Number
    1221359-2021-03283
    Event Type
    Malfunction
    Date Received
    October 26, 2021
    Date of Event
    October 3, 2021
    Report Date
    December 9, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    04571226475027
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: H10: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT M162377 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 191-000 / LOT: M162377, TEST BASE PART NUMBER 190-430 / LOT: M162377. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT M162377 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 PATIENT SAMPLE INTERFERENCE. SUBSTANCES IN THE SAMPLE ITSELF MAY HAVE INTERFERED WITH THE REACTION.

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FALSE POSITIVE RESULT ON A DIRECT TESTED NASOPHARYNGEAL SWAB WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2021. SINCE THE RESULT WAS POSITIVE AND THE PATIENT'S WATER BROKE, THE PATIENT WAS NOT ADMITTED TO THE FACILITY AND HAD TO BE TRANSFERRED TO ANOTHER FACILITY. CONFIRMATION TESTING WAS PERFORMED THREE TIMES AND GENERATED NEGATIVE RESULTS (CT VALUES NOT PROVIDED). PER THE CUSTOMER, THERE WAS NO PATIENT HARM DUE TO THE RESULTS. THERE WAS DELAY IN TREATMENT SINCE THE PATIENT HAD TO BE TRANSFERRED TO ANOTHER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1594998 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M162377 04571226475027

    Patients

    Seq Age Sex Outcome Treatment
    1 Female