BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C702 MODULE

    MDR report key: 23478960 · Received November 5, 2025

    Report

    Report Number
    1823260-2025-04517
    Event Type
    Malfunction
    Date Received
    November 5, 2025
    Date of Event
    October 17, 2025
    Report Date
    December 22, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THAT THE ROOT CAUSE WAS CONSISTENT WITH THE STANDBY REAGENT BECOMING THE CURRENT REAGENT BEING USED WITHOUT A QC BEING MEASURED FOR IT PREVIOUSLY. PER LABELING, "YOU MUST PERFORM QC MEASUREMENTS WHEN A NEW REAGENT CASSETTE IS LOADED TO CHECK THE REAGENT."

    Additional Manufacturer Narrative · 0

    THE VANC3 REAGENT LOT NUMBER IS 823162, AND THE EXPIRATION DATE WAS NOT PROVIDED. A FIELD SERVICE ENGINEER (FSE) OBSERVED CONTAMINATION OF SAMPLE PROBES A AND B, CONTAMINATION OF THE WASHING TANKS, AND THE GEAR PUMP PRESSURE WAS NOT CORRECT. THE FSE CLEANED THE SAMPLE PROBES AND THE WASHING TANK, AND THE CLEANING MECHANISM NOZZLE. THE FSE ADJUSTED THE PROBE CLEANING TANK WATER AMOUNT AND THE GEAR PUMP HEAD PRESSURE, AND THE CELL CLEANING WATER AMOUNT. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF A QUESTIONABLE VANC3 RESULT FROM THE COBAS 8000 C702 MODULE FOR ONE PATIENT. THE INITIAL TROUGH VALUE RESULT WAS 5.8 G/ML. THE REPEAT TROUGH VALUE RESULT ON ANOTHER ANALYZER WAS 10.1 G/ML. THE INITIAL PEAK VALUE RESULT WAS 8.6 G/ML. THE REPEAT PEAK VALUE RESULT ON ANOTHER ANALYZER WAS 14.0 G/ML. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2636542 COBAS 8000 C702 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown