BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION® CLINICAL CHEMISTRY SYSTEM

    MDR report key: 1843164 · Received September 23, 2010

    Report

    Report Number
    1226181-2010-00122
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Date of Event
    August 29, 2010
    Report Date
    August 30, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    MMI
    PMA / PMN Number
    K010061
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROBABLE CAUSE OF THE FALSELY ELEVATED TROPONIN I RESULT WAS IMPRECISION CAUSED BY THE HETEROGENEOUS MODULE. THE CUSTOMER WAS INSTRUCTED BY A SIEMENS REPRESENTATIVE TO PERFORM MAINTENANCE ON THE SYSTEM. THE INSTRUMENT IS NOW 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. IT IS UNKNOWN IF THE RESULT WAS REPORTED TO THE PHYSICIAN. NEGATIVE TROPONIN I RESULTS WERE OBTAINED ON REPEATED TESTING OF THE SAME SAMPLE AND ON A SECOND DRAW. THERE WAS NO REPORT OF ANY 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 DIMENSION® CLINICAL CHEMISTRY SYSTEM CLINICAL CHEMISTRY SYSTEM MMI SIEMENS HEALTHCARE DIAGNOSTICS XPAND

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR