BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 1063647 · Received June 19, 2008

    Report

    Report Number
    1823260-2008-04858
    Event Type
    Malfunction
    Date Received
    June 19, 2008
    Date of Event
    May 27, 2008
    Report Date
    June 19, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEM
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    TWO PT SAMPLES WITH DISCREPANT TOTAL BILRUBIN RESULTS PT1: INITIAL RESULT GAVE 0.3 MG/DL; REPEAT GAVE 2.5 MG/DL. INITIAL RESULTS WERE REPORTED. PTS NOT ADVERSELY AFFECTED. ALTHOUGH THE EXACT ROOT CAUSE WAS NOT DETERMINED THE FIELD SERVICE REP ADJUSTED THE GEAR PUMP, CLEANED INCUBATION BATH AND ULTRASONIC MIXERS, REPLACED REACTION CELLS AND PHOTOMETER LAMP. IT WAS ALSO NOTED THE USER ADJUSTED THE DECIMAL PLACEMENT FOR RESULT REPORTING WITHOUT RECALIBRATION AND OUTLINED IN PRODUCT LABELING. PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPECIFICATION.

    Description of Event or Problem · 2

    TWO PT SAMPLES WITH DISCREPANT TOTAL BILRUBIN RESULTS. PT 2: INITIAL RESULT GAVE 0.2 MG/DL; REPEAT GAVE 1.61 MG/DL. INITIAL RESULTS WERE REPORTED. PTS NOT ADVERSELY AFFECTED. ALTHOUGH THE EXACT ROOT CAUSE WAS NOT DETERMINED THE FIELD SERVICE REP ADJUSTED THE GEAR PUMP, CLEANED INCUBATION BATH AND ULTRASONIC MIXERS, REPLACED REACTION CELLS AND PHOTOMETER LAMP. IT WAS ALSO NOTED THE USER ADJUSTED THE DECIMAL PLACEMENT FOR RESULT REPORTING WITHOUT RECALIBRATION AND OUTLINED IN PRODUCT LABELING. PERFORMANCE TESTS WERE PERFORMED AND 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 87 YR
    2 59 YR