BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS DIRECT BILIRUBIN REAGENT

    MDR report key: 390752 · Received April 26, 2002

    Report

    Report Number
    9680746-2002-00001
    Event Type
    Malfunction
    Date Received
    April 26, 2002
    Date of Event
    March 27, 2002
    Report Date
    April 26, 2002
    Manufacturer
    OLYMPUS DIAGNOSTICA GMBH (IRISH BRANCH)
    Product Code
    CIG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PATIENT WITH KNOWN BILIARY ATRESIS WAS TESTED USING THE DIRECT BILIRUBIN ASSAY TO ASSESS THE POSSIBLITY OF USING THE CLOSER LABORATORY FACILITY FOR PURPOSES OF ROUTINE FOLLOW-UP AND PATIENT MONITORING; SINCE THE PATIENT'S PRIMARY FACILITY WAS GREATER THAN 2.5 HOURS DISTANT. THE ASSAY RETURNED SAMPLE RESULTS THAT DEMONSTRATED SIGNIFICANTLY LOWERED LEVELS OF CONJUGATED BILIRUBIN THAN EXPECTED THAT WERE NOT DUPLICATED BY OTHER METHODOLOGIES. SAMPLES WERE SUBSEQUENTLY TESTED ON OTHER OLYMPUS SYSTEMS THAT CONFIRMED THAT THE LIMITATION WAS REAGENT AND NOT DUE TO AN ANALYZER MALFUNCTION. THE RESULTS OBTAINED DID NOT PRESENT ANY IMPACT ON THE PATIENT SINCE THE PATIENT CONDITION WAS KNOWN AND THIS TESTING WAS CONDUCTED TO ASSESS THE POSSIBILITY OF USING A SECONDARY FACILITY FOR PATIENT MONITORING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS DIRECT BILIRUBIN REAGENT BILIRUBIN TEST SYSTEM CIG OLYMPUS DIAGNOSTICA GMBH (IRISH BRANCH) NA 8805

    Patients

    Seq Age Sex Outcome Treatment
    1 16 MO Congenital Anomaly| O