BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION CLINICAL CHEMISTRY SYSTEM

    MDR report key: 1000728 · Received February 19, 2008

    Report

    Report Number
    1226181-2008-00017
    Event Type
    Malfunction
    Date Received
    February 19, 2008
    Date of Event
    January 27, 2008
    Report Date
    January 27, 2008
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    MMI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE FALSELY ELEVATED TROPONIN I RESULT WAS A BROKEN IDLER GEAR ON THE R1 ARM. A SIEMENS HEALTHCARE DIAGNOSTICS INC FIELD SERVICE REP WAS DISPATCHED TO THE ACCOUNT AND CORRECTED THE MALFUNCTION. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    A FALSELY ELEVATED TROPONIN I RESULT OF 4.99 NG/ML WAS OBTAINED ON A PT SAMPLE. THE RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAMPLE WAS RETESTED AND A RESULT OF 0.07 NG/ML WAS OBTAINED. PT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSELY ELEVATED TROPONIN I RESULT. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE FALSELY ELEVATED TROPONIN RESULT WAS A BROKEN IDLER GEAR ON THE R1 ARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIMENSION CLINICAL CHEMISTRY SYSTEM CLINICAL CHEMISTRY SYSTEM MMI SIEMENS HEALTHCARE DIAGNOSTICS INC. RXLMAXHM NA

    Patients

    Seq Age Sex Outcome Treatment
    1