BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATUS CS STAT FLUOROMETRIC ANALYZER

    MDR report key: 1070548 · Received July 2, 2008

    Report

    Report Number
    2517506-2008-00064
    Event Type
    Malfunction
    Date Received
    July 2, 2008
    Date of Event
    June 2, 2008
    Report Date
    June 2, 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
    NH, 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 FALSELY ELEVATED TROPONIN I RESULTS WERE NOT SPECIFIC BINDING INTERFERENCE. THE INSTRUMENT IS PERFORMING WITHIN SPECS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    THREE FALSELY ELEVATED TROPONIN I RESULTS WERE OBTAINED ON A PT'S SAMPLES. THE RESULTS WERE REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THE SAMPLES WERE REPEATED AND NEGATIVE RESULTS WERE OBTAINED. PT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSELY ELEVATED TROPONIN I RESULTS.

    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 238091002

    Patients

    Seq Age Sex Outcome Treatment
    1