BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION EXL WITH LM

    MDR report key: 2830745 · Received November 13, 2012

    Report

    Report Number
    1226181-2012-00123
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Date of Event
    October 14, 2012
    Report Date
    October 15, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    MMI
    PMA / PMN Number
    K944093
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE ANALYZED THE INSTRUMENT. THE CAUSE OF THE DISCORDANT HIGH TNI RESULT IS UNKNOWN. THE FSE PERFORMED INSTRUMENT MAINTENANCE. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. FURTHER EVALUATION OF THE DEVICE IS NOT REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT HIGH TROPONIN I (TNI) RESULT WAS OBTAINED ON A DIMENSION EXL INSTRUMENT. THE FIRST SAMPLE DRAWN WAS NEGATIVE. THE SECOND SAMPLE WAS DRAWN WHICH HAD A POSITIVE RESULT. A RERUN OF THE SECOND SAMPLE WAS ALSO POSITIVE. THE THIRD SAMPLE WAS DRAWN AND RUN ON A DIFFERENT INSTRUMENT WITH A NEGATIVE RESULT. THE NEGATIVE RESULTS WERE CONSISTENT WITH THE PATIENT'S CLINICAL PICTURE. THERE WAS NO FURTHER PATIENT INTERVENTION. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT HIGH TNI RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIMENSION EXL WITH LM IMMUNOASSAY ANALYZER MMI SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION EXL WITH LM EA3180

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR