BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATUS® CS STAT FLUOROMETRIC ANALYZER

    MDR report key: 2823106 · Received November 7, 2012

    Report

    Report Number
    1226181-2012-00120
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    September 23, 2012
    Report Date
    October 8, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - BROOKFIELD
    Product Code
    JHX
    PMA / PMN Number
    K984067
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    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 MISALIGNMENT OF THE PIPETTOR. A SIEMENS HEALTHCARE DIAGNOSTICS INC. FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE SITE TO PERFORM INSTRUMENT REPAIRS INCLUDING REALIGNMENT OF THE PIPETTOR. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT ELEVATED TROPONIN I RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED AND A NEGATIVE RESULT WAS OBTAINED. IT IS UNKNOWN IF PATIENT TREATMENT WAS 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