BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR

    MDR report key: 1240879 · Received November 10, 2008

    Report

    Report Number
    2432235-2008-00137
    Event Type
    Other
    Date Received
    November 10, 2008
    Date of Event
    October 24, 2008
    Report Date
    October 24, 2008
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    MMI
    PMA / PMN Number
    K971418
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS DUE TO AN OPERATOR ERROR. THE OPERATOR PLACED THE BASE IN THE WASH 1 POSITION ON THE ADVIA CENTAUR INSTRUMENT. A SIEMENS HEALTHCARE TECHNICAL SUPPORT CENTER (TSC) REPRESENTATIVE INSTRUCTED THE CUSTOMER TO DECONTAMINATE THE SYSTEM AND VERIFY ASSAY PERFORMANCE WITH THE QC. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCREPANT ELEVATED ADVIA CENTAUR TROPONIN RESULTS WERE OBTAINED DUE TO AN OPERATOR ERROR. THE OPERATOR PLACED THE BASE IN THE WASH 1 POSITION ON THE INSTRUMENT. THE TROPONIN RESULTS WERE REPORTED TO THE ER DOCTOR. THE SAMPLES WERE REPEATED AT THE DOCTOR'S REQUEST AND THE INITIAL RESULTS WERE CORRECTED. THERE WAS O PATIENT INTERVENTION OR REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCREPANT TROPONIN RESULTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1