BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMMULITE 2500

    MDR report key: 1879579 · Received October 14, 2010

    Report

    Report Number
    2247117-2010-00040
    Event Type
    Other
    Date Received
    October 14, 2010
    Date of Event
    September 8, 2010
    Report Date
    September 13, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJQ
    PMA / PMN Number
    K905215
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DISCORDANT HIGH IMMULITE 2500 TROPONIN RESULTS WERE OBTAINED WITH PLASMA SAMPLES FOR TWO (2) PATIENTS. THE INITIAL AND REPEAT RESULTS FOR BOTH PATIENTS WERE POSITIVE FOR TROPONIN ON IMMULITE 2500. THE SAMPLES FOR BOTH PATIENTS (INCLUDING AN ADDITIONAL SAMPLE DRAWN FOR PATIENT #2) WERE ALSO TESTED FOR TROPONIN T ON THE LABORATORY'S ROCHE ELECSYS SYSTEM, AND THE RESULTS WERE NEGATIVE. THE DISCORDANT TROPONIN RESULTS WERE NOT REPORTED TO THE PHYSICIAN. 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 IMMULITE 2500 IMMUNO-ASSAY JJQ SIEMENS HEALTHCARE DIAGNOSTICS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1