BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR

    MDR report key: 1082427 · Received July 21, 2008

    Report

    Report Number
    2432235-2008-00086
    Event Type
    Malfunction
    Date Received
    July 21, 2008
    Date of Event
    June 21, 2008
    Report Date
    June 23, 2008
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    MMI
    PMA / PMN Number
    K971418
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS HEALTHCARE FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE SITE. ANALYSIS OF THE INSTRUMENT, AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCORDANT RESULTS WERE DUE TO A BROKEN STRAW IN THE WASH 1 BOTTLE RESULTING IN NO DELIVERY WASH 1. THE INSTRUMENT WAS REPAIRED. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT RESULTS WERE OBTAINED FOR TROPONIN ON NINE PT SAMPLES. THE RESULTS WERE REPORTED. NEW REPORTS WERE ISSUED AFTER SAMPLES WERE REPEATED. PT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES, DUE TO THE DISCORDANT TROPONIN OR BNP RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR IMMUNO-ASSAY ANALYZER MMI SIEMENS HEALTHCARE DIAGNOSTICS INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1