BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 22043212 · Received May 19, 2025

    Report

    Report Number
    1823260-2025-01531
    Event Type
    Malfunction
    Date Received
    May 19, 2025
    Date of Event
    April 26, 2025
    Report Date
    May 19, 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 WITH AN EXPIRATION DATE OF 31-MAR-2026. REAGENT ISSUES WERE EXCLUDED AS THE CUSTOMER HAD NO FURTHER ISSUES, AND THE CORRECT REPEAT RESULT WAS RECEIVED USING THE SAME REAGENT. THE FIELD SERVICE ENGINEER (FSE) REPLACED THE VACUUM UNIT, FIXED A VACUUM TUBE ON THE VACUUM BOTTLE, READJUSTED THE CELL RINSE LEVELS, AND CONFIRMED THE MODULE WAS OPERATING WITHIN SPECIFICATION. THE SERVICE ACTIONS RESOLVED THE ISSUE. AS VARIOUS SERVICE ACTIONS WERE PERFORMED, THE SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 0

    THE INITIAL REPORTER COMPLAINED OF DISCREPANT HIGH RESULTS FOR 3 PATIENT SAMPLES TESTED FOR CALCIUM GEN.2 (CA2) ON A COBAS C 501 MODULE. PATIENT 1 INITIAL RESULT WAS 13.8 MG/DL. THE REPEAT RESULT WAS 9.32 MG/DL. PATIENT 2 INITIAL RESULT WAS 14.97 MG/DL. THE REPEAT RESULT WAS 9.36 MG/DL. PATIENT 3 INITIAL RESULT WAS 14 MG/DL. THE REPEAT RESULT WAS 8.9 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164298 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS 04015630924707

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown