BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO

    MDR report key: 11634003 · Received April 8, 2021

    Report

    Report Number
    1823260-2021-01073
    Event Type
    Malfunction
    Date Received
    April 8, 2021
    Date of Event
    March 11, 2021
    Report Date
    April 28, 2021
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JZO
    PMA / PMN Number
    K051890
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A GENERAL PRODUCT ISSUE CAN BE EXCLUDED. THE NEGATIVE AUTOANTIBODY RESULTS MATCH WITH THE RESULTS GENERATED WITH ABBOTT ARCHITECT. THE RESPECTIVE METHODS ARE IN THE SAME RANGE IN RELATION TO THE REFERENCE VALUES AND THEREWITH HAVE THE SAME CLINICAL INTERPRETATION. A REAGENT ISSUE OR INTERFERING FACTORS AFFECTING ELECSYS ASSAYS CAN BE EXCLUDED.

    Additional Manufacturer Narrative · 1

    UDI NUMBER = (B)(4). THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO ON A COBAS 8000 E 801 MODULE. THE RESULTS OBTAINED WITH THE ROCHE METHOD AND A COMPETITOR METHOD DID NOT AGREE WITH THE CLINICAL PICTURE OF THE PATIENT. IT IS NOT KNOWN IF ANY INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS TESTED FOR OTHER PARAMETERS ON THE CUSTOMER'S ANALYZER AND THEN SENT FOR INVESTIGATION. DURING INVESTIGATIONS, THE SAMPLE WAS TESTED ON AN E 801 ANALYZER, RESULTING IN AN ANTI-TPO VALUE OF < 9.00 IU/ML (REFERENCE RANGE = < 30 IU/ML). THE SAMPLE WAS ALSO TESTED ON AN ABBOTT ARCHITECT ANALYZER, RESULTING IN AN ANTI-TPO VALUE OF < 0.50 IU/ML (REFERENCE RANGE = < 5.61 IU/ML). THE SERIAL NUMBER OF THE E 801 ANALYZER IS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531614 ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO SYSTEM, TEST, THYROID AUTOANTIBODY JZO ROCHE DIAGNOSTICS NA 522679

    Patients

    Seq Age Sex Outcome Treatment
    1