BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C 702 MODULE

    MDR report key: 20928629 · Received December 13, 2024

    Report

    Report Number
    1823260-2024-03672
    Event Type
    Malfunction
    Date Received
    December 13, 2024
    Date of Event
    November 26, 2024
    Report Date
    June 18, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REAGENT LOT NUMBER WAS 832324. THE EXPIRATION DATE WAS NOT PROVIDED. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE ENGINEER ADJUSTED THE PUMP PRESSURE, REPLACED THE GEAR PUMP HEAD, ADJUSTED THE ULTRASONIC MIXER, CHECKED THE CUVETTE RINSE, CHECKED THE PROBES, ADJUSTED THE PROBE WASHES, REPLACED THE PROBES, AND ADJUSTED THE WATER BATH LEVEL. MULTIPLE HARDWARE CHECKS WERE PERFORMED AND WERE ACCEPTABLE. SAMPLES FROM THE CUSTOMER'S WATER TANK WERE COLLECTED AND FOUND TO HAVE PSEUDOMONAS BACTERIA. THE INVESTIGATION DETERMINED THAT THE SERVICE ACTION RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE CREATININE RESULTS FROM THE COBAS 8000 C702 MODULE. SAMPLE 1 INITIAL RESULT WAS 27.5 UMOL/L. THE REPEAT RESULTS WERE 63.9 UMOL/L AND 65.8 UMOL/L. SAMPLE 2 INITIAL RESULT WAS 122.6 UMOL/L. THE REPEAT RESULTS WERE 69 UMOL/L AND 68.3 UMOL/L. THE FINAL REPEAT RESULT WAS BELIEVED CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1936456 COBAS 8000 C 702 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown