BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C702 MODULE

    MDR report key: 21547038 · Received March 7, 2025

    Report

    Report Number
    1823260-2025-00657
    Event Type
    Malfunction
    Date Received
    March 7, 2025
    Date of Event
    February 11, 2025
    Report Date
    March 28, 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

    A FIELD SERVICE ENGINEER (FSE) CHECKED THE ANALYZER AND PERFORMED A SERIES OF TROUBLESHOOTING STEPS, INCLUDING PREVENTATIVE SERVICE MAINTENANCE. A DIRECT ROOT CAUSE COULD NOT BE DETERMINED. THE INVESTIGATION DETERMINED THAT THE SERVICE ACTION RESOLVED THE ISSUE.

    Additional Manufacturer Narrative · 0

    THE REAGENT LOT NUMBERS AND EXPIRATION DATES WERE NOT PROVIDED. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE CREATININE JAFFE GEN.2 AND ALBUMIN RESULTS FROM THE COBAS 8000 C702 MODULE. FOR SAMPLE (B)(6) THE INITIAL ALBUMIN RESULT WAS 75.3 G/DL, AND THE REPEAT RESULTS WERE 47.8 G/DL, 44.6 G/DL, AND 43.9 G/DL. FOR SAMPLE (B)(6) THE INITIAL URINE ALBUMIN RESULT WAS 233.9 G/DL, AND THE REPEAT RESULTS WERE 12.8 G/DL, 12.7 G/DL, AND 13.4 G/DL. FOR SAMPLE (B)(6) THE INITIAL ALBUMIN RESULT WAS 64.1 G/DL, AND THE REPEAT RESULTS WERE 45.1 G/DL, 41.2 G/DL, AND 40.8 G/DL. FOR SAMPLE (B)(6) THE INITIAL CREATININE RESULT WAS 11.1 MOL/L, AND THE REPEAT RESULTS WERE 76.7 MOL/L AND 75.8 MOL/L. FOR SAMPLE (B)(6) THE INITIAL ALBUMIN RESULT WAS 78.0 G/DL, AND THE REPEAT RESULTS WERE 48.9 G/DL, 42.7 G/DL, AND 45.3 G/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434723 COBAS 8000 C702 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown