BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR TROPONIN ULTRA ASSAY

    MDR report key: 1080212 · Received July 17, 2008

    Report

    Report Number
    1219913-2008-00060
    Event Type
    Other
    Date Received
    July 17, 2008
    Date of Event
    June 17, 2008
    Report Date
    July 2, 2008
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    MMI
    PMA / PMN Number
    K053020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCORDANT TROPONIN RESULTS IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THREE POSITIVE ADVIA CENTAUR TROPONIN ULTRA PATIENT RESULTS TO THE PHYSICIAN. AFTER THE HIGH RESULTS WERE REPORTED, THE TECHNICIAN RAN QC AND IT WAS HIGH AND OUT OF RANGE. THE PATIENT SAMPLES WERE THEN RUN ON ANOTHER CENTAUR AND THE TROPONIN ULTRA RESULTS WERE NEGATIVE. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TROPONIN ULTRA RESULTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1