BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501MODULE

    MDR report key: 1172481 · Received September 19, 2008

    Report

    Report Number
    1823260-2008-07012
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    August 27, 2008
    Report Date
    September 19, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    USER RECEIVING DIFFERENT RESULTS ON ONE PROFICIENCY SAMPLE FOR LIPASE AND AST. INITIAL LIPASE RESULT 3 IU, REPEAT 74 IU, INITIAL AST 71 IU, REPEAT 116 IU. NO PATIENT SAMPLES WERE AFFECTED. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE THE CAUSE AND COULD NOT DUPLICATE THE ISSUE. HE NOTED HE CHECKED THE ANALYZER. PERFORMANCE TESTS WERE PERFORMED WHICH WERE WITHIN SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 6000 C501MODULE CLINICAL CHEMISTRY ANALYZER - CEM JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK