BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 23334964 · Received October 20, 2025

    Report

    Report Number
    1823260-2025-04246
    Event Type
    Malfunction
    Date Received
    October 20, 2025
    Date of Event
    October 7, 2025
    Report Date
    October 20, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630924714
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE TROPONIN T REAGENT LOT NUMBER WAS 827211. THE CKMB REAGENT LOT NUMBER WAS 825291. THE EXPIRATION DATES WERE NOT PROVIDED. THE FIELD SERVICE ENGINEER CHECKED THE SYSTEM, GEAR PUMP PRESSURE, PROBE ADJUSTMENTS, AND WATER FLOW AND DRAINAGE. HE FOUND THE BEAD PADDLE MIXER WAS DRIPPING. HE WIPED THE PROBES, FLUSHED THE WASH STATIONS, AND PRIMED THE SYSTEM. HE RAN ANALYZER PERFORMANCE TESTING AND QC, WHICH PASSED. NO QC WAS MEASURED BEFORE THE SUSPICIOUS SAMPLE WAS TESTED. GOOD LABORATORY PRACTICE PRECLUDES RUNNING AND/OR REPORTING PATIENT RESULTS WHEN QUALITY CONTROL HAS NOT BEEN PERFORMED. NO RELEVANT ANALYZER ALARMS OCCURRED AT THE TIME OF THE EVENT. THE INVESTIGATION WAS UNABLE TO DETERMINE A SPECIFIC ROOT CAUSE.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FROM THE COBAS 6000 E601 MODULE. THE INITIAL TROPONIN T RESULT WAS 14.16 PG/ML, AND THE REPEAT RESULT WAS 578.8 PG/ML. THE INITIAL CKMB RESULT WAS 0.378 NG/ML, AND THE REPEAT RESULT WAS 12.44 NG/ML. THE PATIENT WAS REDRAWN, AND THE RESULTS FOR THE NEW SAMPLE MATCHED THE REPEAT RESULTS. THE TROPONIN T RESULTS WERE 565.6 PG/ML AND 548. 1 PG/ML. THE CKMB RESULTS WERE 10.78 NG/ML AND 10.81 NG/ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2765106 COBAS 6000 E601 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E601 04015630924714

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female