BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMMULITE 2500, TURBO TROPONIN I ASSAY

    MDR report key: 1070840 · Received July 1, 2008

    Report

    Report Number
    2017183-2008-00017
    Event Type
    Other
    Date Received
    July 1, 2008
    Date of Event
    April 13, 2008
    Report Date
    April 15, 2008
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    MMI
    PMA / PMN Number
    K034055
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCORDANT TROPONIN I RESULT IS UNK. THE INSTRUMENT IS PERFORMING WITHIN SPECS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A POSITIVE IMMULITE 2500 TROPONIN I PT SAMPLE WAS REPORTED TO THE PHYSICIAN. THE RESULT WAS QUESTIONED AND THE PT WAS REDRAWN. THE REDRAWN SAMPLE TROPONIN RESULT WAS NEGATIVE. PT TREATMENT WAS NOT ALTERED. THERE WAS NO 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, TURBO TROPONIN I ASSAY TROPONIN IMMUNOASSAY MMI SIEMENS HEALTHCARE DIAGNOSTICS NA 131

    Patients

    Seq Age Sex Outcome Treatment
    1