BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATUS CS STAT FLUOROMETRIC ANALYZER

    MDR report key: 1070529 · Received July 2, 2008

    Report

    Report Number
    1226181-2008-00079
    Event Type
    Malfunction
    Date Received
    July 2, 2008
    Date of Event
    June 11, 2008
    Report Date
    June 11, 2008
    Manufacturer
    DADE BEHRING, INC.
    Product Code
    JJE
    PMA / PMN Number
    K984067
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS HEALTHCARE DIAGNOSTICS, INC. FIELD SERVICE REP (FSE) WAS DISPATCHED TO THE ACCOUNT. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE FALSELY ELEVATED TROPONIN I RESULT WAS THE PIPETTOR AND PUMP PANEL. THE FSE CORRECTED THE MALFUNCTION. 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 NOT WAS REPORTED TO THE PHYSICIAN. THE SAMPLE WAS REPEATED AND A NEGATIVE RESULT WAS 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 RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRATUS CS STAT FLUOROMETRIC ANALYZER CLINICAL CHEMISTRY SYSTEM JJE DADE BEHRING, INC. SCS NA

    Patients

    Seq Age Sex Outcome Treatment
    1