BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C702 MODULE

    MDR report key: 24473059 · Received February 27, 2026

    Report

    Report Number
    1823260-2026-00731
    Event Type
    Malfunction
    Date Received
    February 27, 2026
    Date of Event
    February 12, 2026
    Report Date
    February 27, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE TINA-QUANT ALBUMIN GEN.2 REAGENT LOT NUMBER IS 883907, AND THE EXPIRATION DATE WAS NOT PROVIDED. A FIELD SERVICE ENGINEER (FSE) DETERMINED THAT THE TUBING OF THE VACUUM NOZZLE IN THE CUVETTE WASHING STATION WAS DAMAGED AND REPLACED IT. THE FSE PERFORMED MULTIPLE TROUBLESHOOTING-RELATED ACTIONS. THE CUSTOMER HAS NOT REPORTED ANY FURTHER ISSUES SINCE THE FSE'S SERVICE ACTIONS WERE COMPLETED. THE INVESTIGATION DETERMINED THAT THE SERVICE ACTION RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF A QUESTIONABLE TINA-QUANT ALBUMIN GEN.2 RESULT FROM THE COBAS 8000 C702 MODULE FOR ONE URINE PATIENT SAMPLE. THE INITIAL RESULT WAS 210.8 MG/L, AND THE REPEAT RESULT WAS 27.6 MG/L. THE REPEAT RESULT WAS DEEMED TO BE CORRECT. THE QUESTIONABLE RESULT WAS NOT RELEASED FROM THE LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529528 COBAS 8000 C702 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown