BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS ANTI-TPO

    MDR report key: 19884620 · Received August 1, 2024

    Report

    Report Number
    1823260-2024-02234
    Event Type
    Malfunction
    Date Received
    August 1, 2024
    Date of Event
    July 5, 2024
    Report Date
    September 10, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JZO
    PMA / PMN Number
    K051890
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CALIBRATION RECOVERY DATA PROVIDED WAS ACCEPTABLE. IT WAS FOUND THAT THE CUSTOMER DID NOT PERFORM QC ON EITHER DAY OF THE PATIENT SAMPLE BEING TESTED. IT WAS ALSO FOUND THAT THE ACTIVE TUBE GRIPPER WAS INCORRECTLY ADJUSTED AND DIRTY AND THE MEASURING CELLS WERE EXPIRED. BASED ON THE AVAILABLE DATA, A GENERAL REAGENT ISSUE COULD BE EXCLUDED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Additional Manufacturer Narrative · 0

    THE ANALYZER SERIAL NUMBER IS (B)(6). THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO RESULTS FOR 1 PATIENT SERUM SAMPLE ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 40.4 IU/ML. THE NEXT DAY, AN ALIQUOT OF THE SAMPLE WAS REPEATED IN A SAMPLE CUP TWICE AND THE RESULTS WERE BOTH 9.00 IU/ML WITH FLAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732991 ELECSYS ANTI-TPO SYSTEM, TEST, THYROID AUTOANTIBODY JZO ROCHE DIAGNOSTICS 76913801

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown