BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C702 MODULE

    MDR report key: 23659509 · Received November 26, 2025

    Report

    Report Number
    1823260-2025-04883
    Event Type
    Malfunction
    Date Received
    November 26, 2025
    Date of Event
    November 7, 2025
    Report Date
    November 26, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE TOTAL PROTEIN REAGENT LOT WAS 851295. THE CALCIUM REAGENT LOT WAS 841368. THE GLUCOSE REAGENT LOT WAS 869383. THE EXPIRATION DATES WERE NOT PROVIDED. THE LAMP, CUVETTE, AND SAMPLE PROBES WERE REPLACED SINCE THE CUVETTES APPEARED TO BE OVERFLOWING. THE WASHING, DRYING, THE ULTRASONIC MIXER (USM) ADJUSTMENT, AND THE RINSE ADJUSTMENT WERE CHECKED. A GENERAL REAGENT ISSUE WAS EXCLUDED, AS THE RESULTS BELIEVED TO BE CORRECT WERE OBTAINED USING THE SAME REAGENT. THE FIELD SERVICE ENGINEER REPLACED THE LAMP AND CUVETTES AGAIN AND REPLACED THE VALVES OF THE SAMPLING SYRINGES AND THE DEGASSER. AFTERWARDS, THE HARDWARE PERFORMANCE CHECK WAS ACCEPTABLE. THE INVESTIGATION DETERMINED THAT THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FOR MULTIPLE ASSAYS FROM THE COBAS 8000 C702 MODULE. EXAMPLE 1 INITIAL TOTAL PROTEIN RESULT WAS 52.1 G/L, AND THE REPEAT RESULT WAS 72 G/L. EXAMPLE 2 INITIAL TOTAL PROTEIN RESULT WAS 44.1 G/L, AND THE REPEAT RESULT WAS 76.1 G/L. EXAMPLE 3 INITIAL CALCIUM RESULT WAS 5.13 MG/DL, AND THE REPEAT RESULT WAS 9.28 MG/DL. EXAMPLE 4 INITIAL CALCIUM RESULT WAS 7.83 MG/DL, AND THE REPEAT RESULT WAS 9.74 MG/DL. EXAMPLE 5 INITIAL GLUCOSE RESULT WAS 15 MG/DL, AND THE REPEAT RESULT WAS 93 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2538640 COBAS 8000 C702 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown