BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMMULITE 2500

    MDR report key: 1887073 · Received October 1, 2010

    Report

    Report Number
    2247117-2010-00039
    Event Type
    Other
    Date Received
    October 1, 2010
    Date of Event
    September 11, 2010
    Report Date
    September 11, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJQ
    PMA / PMN Number
    K905215
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    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 DISCREPANT TROPONIN RESULTS IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT HIGH IMMULITE 2500 TROPONIN (RTI) RESULT WAS OBTAINED WITH ONE (1) PT SAMPLE. THE SAMPLE WAS INITIALLY TESTED (IN DUPLICATE) PER THE LABORATORY'S PROTOCOL. THE SAMPLE WAS TESTED A THIRD TIME AFTER A REVIEW OF THE RESULTS INDICATED A >20% DIFFERENCE BETWEEN THE TWO RESULTS. THE INITIAL RESULT (FIRST REPLICATE) WAS RELEASED TO THE PHYSICIAN. PT TREATMENT WAS NOT ALTERED OR PRESCRIBED. 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