BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 1032578 · Received April 21, 2008

    Report

    Report Number
    1823260-2008-03441
    Event Type
    Malfunction
    Date Received
    April 21, 2008
    Date of Event
    March 21, 2008
    Report Date
    April 22, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEM
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER REPORTS DISCREPANT PATIENT RESULTS FOR MULTIPLE ASSAYS. EIGHT PATIENT EXAMPLES PROVIDED, ALL REPEATED USING DIFFERENT METHODOLOGY, UNLESS NOTED. PATIENT 1, 2008, INITIAL AMYLASE RESULT 123 U/L, REPEAT GAVE 81 U/L. PATIENT 2, 2008, INITIAL LIPASE RESULT 46 U/L, REPEAT GAVE 85 U/L. PATIENT 3, 2008, INITIAL CALCIUM RESULT 6.2 MG/DL, REPEAT GAVE 8.6 MG/DL. PATIENT 4, 2008, INITIAL CALCIUM RESULT 5.9 MG/DL, REPEAT GAVE 8.3 MG/DL. PATIENT 5, 2008, INITIAL VANCOMYCIN 141 UG/ML, REPEATED TWICE GIVING 124 (SAME METHODOLOGY) AND 90 UG/ML. PATIENT 6, 2008, INITIAL CALCIUM RESULT 11.2 MG/DL, REPEAT GAVE 9.7 MG/DL. PATIENT 7, 2008, INITIAL CALCIUM RESULT 12.5 MG/DL, REPEAT GAVE 8.1 MG/DL. PATIENT 8, 2008, INITIAL CALCIUM RESULT 12.7 MG/DL, REPEAT GAVE 8.3 MG/DL. THE ERRONEOUS RESULTS WERE NOT REPORTED. FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE ROOT CAUSE BUT NOTED HE REPLACED THE FOLLOWING PARTS; HMTC 100 ASSEMBLY, CIRCUIT BOARD ASSEMBLY DO-A3, VALVE ASSEMBLY AND R1 SYRINGE DRIVE ASSEMBLY. PERFORMANCE TESTS PERFORMED WHICH WERE WITHIN SPECIFICATION.

    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