BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 22306413 · Received June 23, 2025

    Report

    Report Number
    1823260-2025-01903
    Event Type
    Malfunction
    Date Received
    June 23, 2025
    Date of Event
    May 28, 2025
    Report Date
    October 9, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630924707
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CA2 REAGENT LOT NUMBER WAS 850567. THE EXPIRATION DATE WAS NOT PROVIDED. THE NA ELECTRODE LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED. THE CALIBRATION AND QC WERE WITHIN RANGE. THE CUSTOMER PERFORMED WASHINGS, MAINTENANCE, AND CHANGED THE ELECTRODES. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    GENERAL CALCIUM REAGENT AND SODIUM ELECTRODE ISSUES CAN BE EXCLUDED SINCE THE CALIBRATION AND QC DATA WERE WITHIN RANGE. THE FIELD SERVICE ENGINEER FOUND CRYSTALS IN THE RINSE STATION TUBES AND DETECTED A BROKEN TUBE. HE REPLACED THE RINSE STATION TUBES, CLEANED THE VACUUM TANK, AND REPLACED THE SOLENOID VALVE AND THE SAMPLE PROBES. THE INSTRUMENT WAS PERFORMING WITHIN SPECIFICATIONS. THE SERVICE ACTIONS PERFORMED BY THE ENGINEER RESOLVED THE ISSUE IN A REASONABLE AND COMMONLY TRAINED MANNER. NO FURTHER ISSUES WERE REPORTED AFTER THE SERVICE VISIT. THE ROOT CAUSE WAS CONSISTENT WITH A HARDWARE-RELATED ISSUE.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH CALCIUM GEN.2 (CA2) ASSAY AND 1 PATIENT SAMPLE TESTED FOR SODIUM (NA) ON A COBAS 6000 C501 MODULE. SAMPLE 1 WAS TESTED FOR CA2: INITIAL RESULT: 3.6 MG/DL (ACCOMPANIED BY A DATA FLAG). REPEAT RESULT: 8.0 MG/DL. SAMPLE 2 WAS TESTED FOR NA ON (B)(6) 2025: INITIAL RESULT: 160 MMOL/L (ACCOMPANIED BY A DATA FLAG). REPEAT RESULT: 140 MMOL/L. THE SAMPLES WERE AUTOMATICALLY REPEATED BY THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849040 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS 04015630924707

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown