BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 1012736 · Received March 12, 2008

    Report

    Report Number
    1823260-2008-02369
    Event Type
    Malfunction
    Date Received
    March 12, 2008
    Date of Event
    February 12, 2008
    Report Date
    March 12, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEM
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    THREE PT SAMPLES INITIALLY GENERATING LOW RESULTS FOR CO2 AND CALCIUM, WHICH RESULTED HIGHER WHEN REPEATED BY ANOTHER METHODOLOGY. PT 1, INITIAL BICARBONATE (CO2) GAVE 36 MMOL/L; REPEAT GAVE 20 MMOL/L. INITIAL CALCIUM GAVE 8.9 MG/DL; REPEAT GAVE 7.3 MG/DL. PT 2, INITIAL CO2 GAVE 38 MMOL/L; REPEAT GAVE 20 MMOL/L. INITIAL CALCIUM GAVE 11.2 MG/DL; REPEAT GAVE 9.5 MG/DL. PT 3, INITIAL CO2 GAVE 43 MMOL/L; REPEAT GAVE 18 MMOL/L. INITIAL CALCIUM GAVE 11.7 MG/DL; REPEAT GAVE 10.9 MG/DL. INITIAL RESULTS WERE REPORTED. PTS NOT ADVERSELY AFFECTED. THE FIELD SVC REP FOUND A PROBLEM WITH THE MAIN WATER PUMP AND PRIMED MAIN WATER PUMP AS WELL AS PERFORMED NECESSARY MAINTENANCE FUNCTION TO RECOVER THE SYSTEM. PERFORMANCE TESTS WERE PERFORMED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK