BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 COBAS C 701 MODULE

    MDR report key: 23851168 · Received December 19, 2025

    Report

    Report Number
    1823260-2025-05250
    Event Type
    Malfunction
    Date Received
    December 19, 2025
    Date of Event
    December 8, 2025
    Report Date
    December 19, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REAGENT LOT NUMBER IS 916764. THE EXPIRATION DATE WAS REQUESTED BUT WAS NOT PROVIDED. THE FIELD SERVICE ENGINEER (FSE) REPLACED THE CUVETTES, DAMAGED TUBING ON THE WASH STATION, AND ADJUSTED WASH VOLUMES. FOLLOWING THE FSE INTERVENTION, NO FURTHER ISSUE WAS OBSERVED. THE INVESTIGATION DETERMINED THAT THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE CREATININE PLUS VER.2 RESULTS FOR PATIENT SAMPLES TESTED ON A COBAS 8000 COBAS C 701 MODULE. SAMPLE 1: THE INITIAL RESULT WAS 1155 MOL/L. THE REPEAT RESULT USING ANOTHER C701 WAS 139 MOL/L. SAMPLE 2: THE INITIAL RESULT WAS 896 MOL/L. THE REPEAT RESULT USING ANOTHER C701 WAS 54 MOL/L. SAMPLE 3: THE INITIAL RESULT WAS 587 MOL/L. THE REPEAT RESULT USING ANOTHER C701 WAS 99 MOL/L. SAMPLE 4: THE INITIAL RESULT WAS 250 MOL/L. THE REPEAT RESULT USING ANOTHER C701 WAS 122 MOL/L. SAMPLE 5: THE INITIAL RESULT WAS 284 MOL/L. THE REPEAT RESULT USING ANOTHER C701 WAS 60 MOL/L. SAMPLE 6: THE INITIAL RESULT WAS 240 MOL/L. THE REPEAT RESULT USING ANOTHER C701 WAS 64 MOL/L. SAMPLE 7: THE INITIAL RESULT WAS 685 MOL/L. THE REPEAT RESULT USING ANOTHER C701 WAS 62 MOL/L. SAMPLE 8: THE INITIAL RESULT WAS 226 MOL/L. THE REPEAT RESULT USING ANOTHER C701 WAS 107 MOL/L. THE REPEAT RESULTS ARE DEEMED CORRECT. THE TEST WAS REPEATED AS THE VALUES DID NOT MATCH THE PREVIOUS FINDINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258020 COBAS 8000 COBAS C 701 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown