BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR TROPONIN ULTRA ASSAY

    MDR report key: 1242561 · Received November 21, 2008

    Report

    Report Number
    1219913-2008-00097
    Event Type
    Other
    Date Received
    November 21, 2008
    Date of Event
    October 2, 2008
    Report Date
    October 20, 2008
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MMI
    PMA / PMN Number
    K053020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    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

    POSITIVE ADVIA CENTAUR TROPONIN ULTRA RESULTS WERE OBTAINED ON SEVERAL PATIENT SAMPLES. ONE POSITIVE RESULT (B) (6) WAS REPORTED TO THE PHYSICIAN PRIOR TO REPEAT. THE PATIENT SAMPLE WAS REPEATED ON A DIFFERENT SYSTEM AND A NEGATIVE RESULT WAS OBTAINED. THE CORRECTED REPORT WAS SENT TO THE PHYSICIAN. IT IS UNKNOWN IF PATIENT TREATMENT WAS ALTERED OR PRESCRIBED. 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 28

    Patients

    Seq Age Sex Outcome Treatment
    1 Other