BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C702 MODULE

    MDR report key: 22982356 · Received September 5, 2025

    Report

    Report Number
    1823260-2025-02765
    Event Type
    Malfunction
    Date Received
    September 5, 2025
    Date of Event
    August 18, 2025
    Report Date
    September 5, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CALCIUM GEN.2 REAGENT LOT NUMBER IS 841368, AND THE EXPIRATION DATE IS 28-FEB-2026. A FIELD SERVICE ENGINEER (FSE) DETERMINED THAT THE REAGENT AND SAMPLE PROBES WASHING POSITION WAS MISALIGNED. THE INVESTIGATION DETERMINED THAT THE SERVICE ACTION RESOLVED THE ISSUE. NO FURTHER ISSUES HAVE BEEN REPORTED BY THE CUSTOMER.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF A QUESTIONABLE CALCIUM GEN.2 RESULT FROM THE COBAS 8000 C702 MODULE FOR ONE PATIENT. THE INITIAL RESULT WAS 1.61 MMOL/L, AND THE FIRST REPEAT RESULT FROM ANOTHER ANALYZER WAS 2.29 MMOL/L. ANOTHER REPEAT RESULT FROM A DIFFERENT ANALYZER WAS 2.28 MMO/L. THE REPEAT RESULT OF 2.29 MMOL/L WAS DEEMED TO BE CORRECT. THE QUESTIONABLE RESULT WAS NOT RELEASED OUTSIDE OF THE LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2225137 COBAS 8000 C702 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown