BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMMULITE 2500 STAT TROPONIN I

    MDR report key: 1240872 · Received November 6, 2008

    Report

    Report Number
    2017183-2008-00048
    Event Type
    Other
    Date Received
    November 6, 2008
    Date of Event
    September 14, 2008
    Report Date
    September 15, 2008
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    MMI
    PMA / PMN Number
    K034055
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. ANALYSIS OF INSTRUMENT DIDN'T INDICATE SYSTEM ERROR AND SUSPECTED THAT FIBRIN IN THE SAMPLE MAY HAVE CAUSED THE DISCREPANT RESULT. NO FURTHER EVAL OF THE DEVICE IS REQUIRED. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    A NEGATIVE IMMULITE 2500 TROPONIN RESULT WAS OBTAINED ON A PT SAMPLE. THE SAMPLE WAS REPEATED AND THE TROPONIN RESULT WAS POSITIVE. THE SAMPLE WAS RETESTED AGAIN (2X) AND THE TROPONIN RESULTS WERE NEGATIVE WHICH CONFIRMED THE INITIAL NEGATIVE RESULT. PT TREATMENT WAS NOT ALTERED AND THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT STAT TROPONIN ASSAY RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMULITE 2500 STAT TROPONIN I TROPONIN IMMUNOASSAY MMI SIEMENS HEALTHCARE DIAGNOSTICS INC. NA 133

    Patients

    Seq Age Sex Outcome Treatment
    1