BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR TROPONIN ULTRA ASSAY

    MDR report key: 2820425 · Received November 6, 2012

    Report

    Report Number
    1219913-2012-00391
    Event Type
    Malfunction
    Date Received
    November 6, 2012
    Date of Event
    October 16, 2012
    Report Date
    October 17, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MMI
    PMA / PMN Number
    K053020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE. ANALYSIS OF THE INSTRUMENT INDICATES THAT THE CAUSE FOR THE DISCORDANT ADVIA CENTAUR TROPONIN ULTRA RESULT IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATION. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A FALSE POSITIVE ADVIA CENTAUR TROPONIN ULTRA RESULT WAS OBTAINED FOR A PATIENT SAMPLE AND FOUND TO BE DISCORDANT WITH REPEAT PATIENT SAMPLE RESULTS. IT IS UNKNOWN IF PATIENT TREATMENT WAS PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TROPONIN 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. N/A 063

    Patients

    Seq Age Sex Outcome Treatment
    1