BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATUS CS STAT FLUOROMETRIC ANALYZER

    MDR report key: 1070532 · Received July 2, 2008

    Report

    Report Number
    2517506-2008-00060
    Event Type
    Malfunction
    Date Received
    July 2, 2008
    Date of Event
    June 25, 2008
    Report Date
    June 25, 2008
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MMI
    PMA / PMN Number
    K051650
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE FALSELY ELEVATED TROPONIN I RESULT WAS NON SPECIFIC BINDING INTERFERENCE. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A FALSELY ELEVATED TROPONIN I RESULT WAS OBTAINED ON A PT SAMPLE. THE RESULT WAS REPORTED TO THE PHYSICIAN. THE SAMPLE WAS REPEATED AND A NEGATIVE RESULT WAS OBTAINED. THE PT WAS ADMITTED TO THE HOSPITAL. THERE WAS NO REPORTED OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSELY ELEVATED TROPONIN I RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRATUS CS STAT FLUOROMETRIC ANALYZER ACUTE CARE TROPONIN I TEST PAK MMI SIEMENS HEALTHCARE DIAGNOSTICS, INC. NA 238154002

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR