BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 12729780 · Received November 1, 2021

    Report

    Report Number
    1221359-2021-03355
    Event Type
    Malfunction
    Date Received
    November 1, 2021
    Date of Event
    September 17, 2021
    Report Date
    November 24, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    10811877011269
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT: M162758 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: 190-000 / LOT: M162758, TEST BASE PART NUMBER: 190-430 / LOT: M162758. 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: M162758 SHOWED THAT THE COMPLAINT (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE, AS THE LOGFILES WERE NOT PROVIDED; 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. REFERENCE MFR REPORT: 1221359-2021-03354, 1221359-2021-03356.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FOUR (4) FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ASSAY PERFORMED ON 2 DAYS WITH 3 LOT NUMBERS. THIS MFR. ADDRESSES REPORT TWO (2) OF THREE (3) FOR ONE (1) FALSE POSITIVE RESULT ON (B)(6) 2021 WITH LOT NUMBER M162758. THE CUSTOMER REPORTED A FALSE POSITIVE RESULT ON A NASAL SWAB WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2021. CONFIRMATION TESTING WAS PERFORMED ON (B)(6) 2021 WITH DIASORIN AND GENERATED NEGATIVE RESULTS (CT VALUES NOT PROVIDED). ALTHOUGH REQUESTED, ADDITIONAL INFORMATION INCLUDING PATIENT TREATMENT AND OUTCOME WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1625880 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M162758 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown