BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C702 MODULE

    MDR report key: 23568239 · Received November 17, 2025

    Report

    Report Number
    1823260-2025-04661
    Event Type
    Malfunction
    Date Received
    November 17, 2025
    Date of Event
    October 28, 2025
    Report Date
    November 17, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REAGENT LOT NUMBER WAS 883907. THE EXPIRATION DATE WAS NOT PROVIDED. THE FIELD SERVICE ENGINEER CHECKED THE SAMPLE PROBE AND FOUND NO ISSUES. HE REPLACED BOTH NEEDLES AND PERFORMED ADJUSTMENTS. HE REPLACED THE FILTERS ON THE FAN AND COVER BASE. HE CHECKED THE GEAR PUMP PRESSURE AND PERFORMED A PRECISION CHECK. THE INVESTIGATION DETERMINED THAT THE ISSUE WAS RESOLVED BY THE SERVICE ACTIONS. BASED ON THE ASPIRATION ALARMS, A PRE-ANALYTIC ISSUE COULD NOT BE EXCLUDED. CORRECT PRE-ANALYTIC SAMPLE HANDLING IS WITHIN THE CUSTOMER'S RESPONSIBILITY.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE TINA-QUANT ALBUMIN GEN.2 RESULTS FROM THE COBAS 8000 C702 MODULE. THE INITIAL RESULT WAS 1.4 G/L, AND THE REPEAT RESULT WAS 34.9 G/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288385 COBAS 8000 C702 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown