BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATUS® CS STAT FLUOROMETRIC ANALYZER

    MDR report key: 2881815 · Received December 20, 2012

    Report

    Report Number
    1226181-2012-00164
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    November 21, 2012
    Report Date
    November 22, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - BROOKFIELD
    Product Code
    JHX
    PMA / PMN Number
    K984067
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    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 SAMPLE INTEGRITY ISSUE. NO ISSUE WAS NOTED WITH THE INSTRUMENT OR REAGENTS. 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 REPORTED TO THE PHYSICIAN. A REDRAW SAMPLE WAS RUN ON AN ALTERNATE STRATUS CS ANALYZER AND A NEGATIVE RESULT WAS OBTAINED. THE PATIENT WAS ADMITTED FOR OBSERVATION. IT IS UNKNOWN IF PATIENT TREATMENT WAS OTHERWISE 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