BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 1051573 · Received May 19, 2008

    Report

    Report Number
    1823260-2008-04143
    Event Type
    Malfunction
    Date Received
    May 19, 2008
    Date of Event
    April 25, 2008
    Report Date
    May 19, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    ONE PT WITH DISCREPANT TOTAL BILIRUBIN (TBIL) RESULTS REPORTED. NO INFO PROVIDED TO DETERMINE IF RESULTS WERE USED TO GUIDE THERAPY. INITIAL TBIL RESULTS 0.4 MG/DL, REPEATED 11.8 MG/DL ON SECOND (DIFFERENT) ANALYZER. SAME SAMPLE REPEATED 11.7 MG/DL ON ORIGINAL ANALYZER. FIELD SVC REP UNABLE TO DETERMINE ROOT CAUSE AND COULD NOT DUPLICATE THE ISSUE. PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPEC.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 3 DA