BEUDAMED
    FDA Adverse Event Summary report: N

    IMMULITE 2500

    MDR report key: 1962137 · Received January 17, 2011

    Report

    Report Number
    2247117-2011-00004
    Date Received
    January 17, 2011
    Date of Event
    December 21, 2010
    Report Date
    December 21, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    DHA
    PMA / PMN Number
    K033234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS TSE (TECHNICAL SERVICE ENGINEER) EVALUATED THE IMMULITE 2500 INSTRUMENT DATA. ANALYSIS OF THE INSTRUMENT DATA INDICATES THAT THE CAUSE FOR THE DISCORDANT TROPONIN RESULTS IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT IMMULITE 2500 TROPONIN RESULTS WERE OBTAINED ON ONE (1) PATIENT SAMPLE. THE LABORATORY REPEATED THE SAMPLE, AS PER THEIR PROCEDURE TO CONFIRM ALL POSITIVE TROPONIN RESULTS. THE CORRECTED RESULT WAS REPORTED TO THE PHYSICIAN. THERE WAS NO KNOWN REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TROPONIN RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMULITE 2500 IMMUNO-ASSAY DHA SIEMENS HEALTHCARE DIAGNOSTICS N/A

    Patients

    Seq Age Sex Outcome Treatment
    1