BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATUS® CS STAT FLUOROMETRIC ANALYZER

    MDR report key: 2100280 · Received May 24, 2011

    Report

    Report Number
    2517506-2011-00096
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Date of Event
    May 13, 2011
    Report Date
    May 13, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    MMI
    PMA / PMN Number
    K051650
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE FALSELY ELEVATED TROPONIN I RESULT IS SAMPLE INTEGRITY. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED

    Description of Event or Problem · 1

    A FALSELY ELEVATED TROPONIN I RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. A NEW SAMPLE WAS DRAWN AND TESTED ON THE SAME SYSTEM AND A NORMAL TROPONIN I RESULT WAS OBTAINED. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT 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 TESTPAK MMI SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW 231004002

    Patients

    Seq Age Sex Outcome Treatment
    1