BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C (501) MODULE

    MDR report key: 22782714 · Received August 12, 2025

    Report

    Report Number
    1823260-2025-02447
    Event Type
    Malfunction
    Date Received
    August 12, 2025
    Date of Event
    July 18, 2025
    Report Date
    August 12, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630924707
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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 CALIBRATION WAS LAST PERFORMED ON 18-JUL-2025, AND IT WAS ACCEPTABLE. THE QC RECOVERY WAS WITHIN THE ACCEPTABLE RANGE. THE ALARM TRACE DID NOT SHOW ANY ABNORMALITY. THE FIELD SERVICE ENGINEER FOUND THAT THE CAUSE WAS DUE TO A DAMAGED VACUUM RINSE TUBING (COMPONENT FAILURE). HE REPLACED THE RINSE TUBING AND VERIFIED THAT THE INSTRUMENT WAS PERFORMING WITHIN SPECIFICATIONS. THE SERVICE ACTIONS PERFORMED BY THE ENGINEER RESOLVED THE ISSUE. NO FURTHER ISSUES WERE REPORTED AFTER THE SERVICE VISIT.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH CALCIUM GEN.2 (CA2) ASSAY ON A COBAS 6000 C 501 (UL) V MODULE. INITIAL RESULT: 4.68 MG/DL (ACCOMPANIED BY A DATA FLAG). THE CRITICAL RESULT IN THE CUSTOMER'S LABORATORY INFORMATION SYSTEM (LIS) PROMPTED THE REPEAT OF THE SAMPLE. REPEAT RESULT: 6.61 MG/DL (ACCOMPANIED BY A DATA FLAG). NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1339825 COBAS 6000 C (501) MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS 04015630924707

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Female