BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATUS® CS STAT FLUOROMETRIC ANALYZER

    MDR report key: 2803105 · Received October 24, 2012

    Report

    Report Number
    1226181-2012-00101
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Date of Event
    September 25, 2012
    Report Date
    September 25, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - BROOKFIELD
    Product Code
    JHX
    PMA / PMN Number
    K984067
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 WAS A POWER FLUCTUATION OF THE UNIVERSAL POWER SUPPLY POWERING THE STRATUS CS(R) INSTRUMENT. THE UNIVERSAL POWER SUPPLY IS NOT DISTRUBUTED BY SIEMENS HEALTHCARE DIAGNOSTICS. A SIEMENS HEALTHCARE DIAGNOSTICS INC. FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE SITE. THE CUSTOMER IS AWARE OF THE POWER SYSTEM ISSUE. THE STRATUS CS(R) 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 RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAMPLE WAS RE-RUN ON THE SAME ANALYZER AND A NEGATIVE RESULT WAS OBTAINED AND CONFIRMED ON AN ALTERNATE INSTRUMENT SYSTEM. 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 CLINICAL CHEMISTRY SYSTEM JHX SIEMENS HEALTHCARE DIAGNOSTICS INC - BROOKFIELD STRATUS® CS

    Patients

    Seq Age Sex Outcome Treatment
    1