BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMMULITE 2000

    MDR report key: 1810794 · Received August 12, 2010

    Report

    Report Number
    2247117-2010-00022
    Event Type
    Other
    Date Received
    August 12, 2010
    Date of Event
    July 19, 2010
    Report Date
    July 28, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJQ
    PMA / PMN Number
    K970227
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS HEALTHCARE DIAGNOSTICS 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 OF 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 HIGH TROPONIN RESULTS WERE OBTAINED ON TWO (2) PATIENT SAMPLES ON DIFFERENT DATES. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN. THE SAMPLES WERE RETESTED (NO NEW SAMPLE COLLECTION). PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TROPONIN RESULTS.

    Additional Manufacturer Narrative · 2

    A SIEMENS HEALTHCARE DIAGNOSTICS 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 OF 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 · 2

    DISCORDANT HIGH TROPONIN RESULTS WERE OBTAINED ON TWO (2) PATIENT SAMPLES ON DIFFERENT DATES. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN. THE SAMPLES WERE RETESTED (NO NEW SAMPLE COLLECTION). PATIENT 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 2000 IMMUNO-ASSAY JJQ SIEMENS HEALTHCARE DIAGNOSTICS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1
    2