BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 12719390 · Received October 29, 2021

    Report

    Report Number
    1221359-2021-03352
    Event Type
    Malfunction
    Date Received
    October 29, 2021
    Date of Event
    September 8, 2021
    Report Date
    December 10, 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

    THIS INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE PROVIDED. REFERENCE MFR REPORT: 1221359-2021-03353.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS (B)(4) ON RETAINED KIT LOT M162595 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: M162595, TEST BASE PART NUMBER 190-430 / LOT: M162595. 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 M162595 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS (B)(4) WAS UNABLE TO DETERMINE AN ASSIGNABLE ROOT CAUSE AS THE LOGFILES WERE NOT PROVIDED FOR INVESTIGATION, HOWEVER SUBSTANCES IN THE SAMPLE ITSELF MAY HAVE INTERFERED WITH THE REACTION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TWO (2) FALSE NEGATIVE RESULTS WITH THE ID NOW COVID-19 ASSAY PERFORMED ON MULTIPLE DATES. THIS MFR. ADDRESSES REPORT ONE (1) OF TWO (2). THE CUSTOMER REPORTED A FALSE NEGATIVE 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 CORELAB AND GENERATED POSITIVE 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
    1622607 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M162595 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown