BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR TROPONIN ULTRA ASSAY

    MDR report key: 1242554 · Received November 21, 2008

    Report

    Report Number
    1219913-2008-00101
    Event Type
    Other
    Date Received
    November 21, 2008
    Date of Event
    November 3, 2008
    Report Date
    November 3, 2008
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MMI
    PMA / PMN Number
    K053020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 ULTRA RESULT IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATION. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    AN ELEVATED ADVIA CENTAUR TROPONIN ULTRA RESULT WAS OBTAINED ON A PATIENT SAMPLE, WHICH WAS REPORTED TO THE PHYSICIAN. A NEW SAMPLE WAS DRAWN FROM THE PATIENT AND A NEGATIVE TROPONIN ULTRA RESULT WAS OBTAINED. THE FIRST SAMPLE WAS THEN RETESTED AND A NEGATIVE TROPONIN ULTRA RESULT WAS OBTAINED. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TROPONIN ULTRA RESULT.

    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