BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 18980934 · Received March 26, 2024

    Report

    Report Number
    1823260-2024-00917
    Event Type
    Malfunction
    Date Received
    March 26, 2024
    Date of Event
    February 27, 2024
    Report Date
    March 26, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630924707
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ELECTRODE LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE CHECKED THE ADJUSTMENTS OF THE SIPPER AND ISE PROBE, AND MADE SMALL ADJUSTMENTS BUT THE SIPPER NOZZLE WAS DAMAGED DUE TO THE HEIGHT ADJUSTMENT BEING OUT. HE REPLACED THE NOZZLE AND SETUP, CHECKED WATER/DETERGENT LEVELS, AND MADE ADJUSTMENTS. HE PERFORMED CALIBRATION, QC, AND PRECISION CHECKS WITH ACCEPTABLE RESULTS. AFTER SERVICE, NO ISSUES WERE REPORTED BY THE CUSTOMER. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE NA RESULTS FOR 4 PATIENT SAMPLES ON A COBAS 6000 C501 MODULE. PATIENT 1 (ID: (B)(6): THE INITIAL RESULT WAS 141 MMOL/L. THE REPEATED RESULT WAS 134 MMOL/L. PATIENT 2 (ID: (B)(6): THE INITIAL RESULT WAS 139 MMOL/L. THE REPEATED RESULT WAS 132 MMOL/L. PATIENT 3 (ID: (B)(6): THE INITIAL RESULT WAS 138 MMOL/L. THE REPEATED RESULT WAS 130 MMOL/L. PATIENT 4 (ID: (B)(6): THE INITIAL RESULT WAS 132 MMOL/L. THE REPEATED RESULT WAS 124 MMOL/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13526 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS 04015630924707

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown