BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 E 801 MODULE

    MDR report key: 22674635 · Received July 31, 2025

    Report

    Report Number
    1823260-2025-02358
    Event Type
    Malfunction
    Date Received
    July 31, 2025
    Date of Event
    July 1, 2025
    Report Date
    September 4, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630946198
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO CALIBRATION INFLUENCE WAS OBSERVED. QUALITY CONTROLS WERE WITHIN RANGE PRIOR TO THE EVENT. A GENERAL REAGENT OR ANALYZER ISSUE WAS NOT PRESENT. NO RELEVANT ANALYZER ALARMS WERE REPORTED. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    THE ANTI-TPO REAGENT LOT NUMBER WAS 864003. THE REAGENT EXPIRATION DATE WAS REQUESTED, BUT NOT PROVIDED. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS ANTI-TPO ON A COBAS 8000 E 801 MODULE. THE SAMPLE INITIALLY RESULTED IN AN ANTI-TPO VALUE OF 50 IU/ML. THE SAMPLE WAS REPEATED ON A SECOND ANALYZER, RESULTING IN A VALUE OF 9 IU/ML. THE SAMPLE WAS REPEATED ON THE COMPLAINED ANALYZER, RESULTING IN A VALUE OF 9 IU/ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34897 COBAS 8000 E 801 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS 04015630946198

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female