BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 1934699 · Received December 21, 2010

    Report

    Report Number
    1823260-2010-07597
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    December 10, 2010
    Report Date
    December 21, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MQM
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED A DISCREPANT RESULT USING THE TOTAL BILIRUBIN SPECIAL (TBILI) APPLICATION ON THE COBAS C501 MODULE WHEN TESTING WAS PERFORMED ON A NEWBORN. THE CUSTOMER STATED THE INITIAL TBILI OF 8.0 MG/DL WAS REPORTED OUTSIDE THE LABORATORY. THE PHYSICIAN QUESTIONED THE RESULT BECAUSE THE PATIENT HAD NOT BEEN "UNDER THE LAMP" FOR ENOUGH TIME TO HAVE DECREASED THE BILIRUBIN THAT MUCH (THE PREVIOUS RESULT IS UNKNOWN). THE LABORATORY REPEATED THE TEST, OBTAINING A TBILI OF 14.0 MG/DL. THE CUSTOMER STATED THE PATIENT WAS NOT AFFECTED BY THE DISCREPANT RESULT. THE TBILI REAGENT LOT NUMBER WAS 62872801. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE EVENT WAS CAUSED BY A FLUIDICS FAILURE DUE TO THE MISADJUSTMENT OF THE CUVETTE REGULATOR. HE ADJUSTED THE CUVETTE REGULATOR DUE TO IT BEING LOW AND NOT PROPERLY CLEANING THE CELLS. THE FIELD SERVICE REPRESENTATIVE PERFORMED A PRECISION CHECK, WHICH WAS WITHIN SPECIFICATIONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1