BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C702 MODULE

    MDR report key: 23850707 · Received December 19, 2025

    Report

    Report Number
    1823260-2025-05241
    Event Type
    Malfunction
    Date Received
    December 19, 2025
    Date of Event
    December 2, 2025
    Report Date
    April 23, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ALBUMIN REAGENT LOT NUMBER IS 832045, AND THE EXPIRATION DATE WAS NOT PROVIDED. THE CREATININE REAGENT LOT NUMBER IS 839831, AND THE EXPIRATION DATE IS 31-AUG-2026. THE TRIGLYCERIDES REAGENT LOT NUMBER IS 872146, AND THE EXPIRATION DATE WAS NOT PROVIDED. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    A FIELD SERVICE ENGINEER (FSE) CHECKED ALL TUBES AND ROUTED ALL OF THE TUBES ACCORDING TO THE RECOMMENDATIONS, CLEANED THE SURFACE OF THE ANALYZER, CLEANED THE REAGENT DISK COVER, CHECKED AND RE-SEATED ALL OF THE H-CLIPS, AND PERFORMED A SAMPLE PROBE ADJUSTMENT. AS THE FSE PERFORMED A LENGTHY AND COMPLEX TROUBLESHOOTING, A SINGLE ROOT CAUSE COULD NOT BE DETERMINED DURING THE INVESTIGATION. THE INVESTIGATION DETERMINED THAT THE SERVICE ACTION RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE ALBUMIN GEN.2, CREATININE JAFFE GEN.2, AND TRIGLYCERIDES RESULTS FROM THE COBAS 8000 C702 MODULE FOR 13 PATIENTS. PLEASE SEE THE ATTACHMENT FOR THE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2270 COBAS 8000 C702 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown