BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C702 MODULE

    MDR report key: 23233143 · Received October 7, 2025

    Report

    Report Number
    1823260-2025-04084
    Event Type
    Malfunction
    Date Received
    October 7, 2025
    Date of Event
    September 15, 2025
    Report Date
    November 3, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER'S CALIBRATION DATA SHOWED THAT CALIBRATION SIGNALS WERE UNSTABLE. ADDITIONALLY, THERE WERE MANY CALIBRATION ALARMS. THE WATER CONTAINER WAS CLEANED, AND THE CUVETTES WERE REPLACED. THE FIELD SERVICE ENGINEER (FSE) ADJUSTED THE LEVELS OF THE CUVETTE WASHING STATIONS AND THE PIPETTING. THE CUSTOMER HAS NOT COMPLAINED OF ANY FURTHER ISSUES SINCE THE SERVICE VISIT. THE INVESTIGATION DETERMINED THE EVENT WAS MOST CONSISTENT WITH INAPPROPRIATE LEVELS OF THE CUVETTE WASHING STATIONS AND THE MISADJUSTMENT OF THE PIPETTING; HOWEVER, THE SPECIFIC CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    THE CA2 REAGENT LOT NUMBER WAS 882078 WITH AN EXPIRATION DATE OF 31-AUG-2026.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF DISCREPANT LOW RESULTS FOR 3 PATIENT SAMPLES TESTED FOR CALCIUM GEN.2 (CA2) ON A COBAS 8000 C702 MODULE. PATIENT 1 INITIAL RESULT WAS 5.1 MG/DL. THE REPEAT RESULT WAS 9.2 MG/DL. PATIENT 2 INITIAL RESULT WAS 6.9 MG/L. THE REPEAT RESULT WAS 9.1 MG/DL. ON (B)(6) 2025, PATIENT 3 INITIAL RESULT WAS 5.1 MG/DL. THE REPEAT RESULT WAS 9.3 MG/DL. THE SAMPLES WERE REPEATED AS THE LOW RESULTS DID NOT CORRESPOND TO THE PATIENT¿S CLINICAL HISTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2716539 COBAS 8000 C702 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown