BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 13608951 · Received February 26, 2022

    Report

    Report Number
    1221359-2022-00824
    Event Type
    Malfunction
    Date Received
    February 26, 2022
    Date of Event
    February 4, 2022
    Report Date
    May 10, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC
    Product Code
    QJR
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. MFR. REPORT NUMBER 1221359-2022-00825.

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 1048616 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 1048616 , TEST BASE PART NUMBER 190-430 / LOT 1048616. 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 1048616 SHOWED THAT THE COMPLAINT RATE IS (B)(4) (1/54168). ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE HOWEVER, A POSSIBLE ASSIGNABLE ROOT CAUSE IS THAT SUBSTANCES IN THE SAMPLE ITSELF MAY HAVE INTERFERED WITH THE REACTION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTS TWO FALSE POSITIVE PATIENT RESULTS WHEN USING THE ID-NOW COVID-19. IT WAS REPORTED "ONE PATIENT TEST POSITIVE ON THE ID NOW AND THEY RETESTED PATIENT TWICE AND THE RESULTS CAME BACK NEGATIVE. THEY RETESTED ON BDMAX AND BIOFIRE." THEY PERFORMED SAME PROCEDURE WITH A SECOND PATIENT WITH SAME RESULTS. TWO OUT OF THREE TESTS GENERATED NEGATIVE RESULTS AND THE ID NOW GENERATED A POSITIVE RESULT. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED. THIS MFR. REPORT ADDRESSES PATIENT 1 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2358379 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC 1048616

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown