BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION CLINICAL CHEMISTRY SYSTEM

    MDR report key: 1033021 · Received April 22, 2008

    Report

    Report Number
    1226181-2008-00041
    Event Type
    Malfunction
    Date Received
    April 22, 2008
    Date of Event
    March 24, 2008
    Report Date
    March 24, 2008
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    MMI
    PMA / PMN Number
    K944093
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER EVAL OF THE DEVICE IS REQUIRED. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE FALSELY ELEVATED TROPONIN I RESULT WAS FAILURE OF THE HM CASSETTE TO ASPIRATE. A SIEMENS HEALTHCARE DIAGNOSTICS INC FIELD SERVICE REP WAS DISPATCHED TO THE ACCOUNT AND CORRECTED THE MALFUNCTION. THE INSTRUMENT IS PERFORMING WITHIN SPECS.

    Description of Event or Problem · 1

    TWO FALSELY ELEVATED TROPONIN I RESULTS WERE OBTAINED ON PT'S SAMPLES. THE RESULTS WERE REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULTS. THE SAMPLES WERE RETESTED AND NEGATIVE RESULTS WERE 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 RESULTS. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE FALSELY ELEVATED TROPONIN I RESULTS WAS FAILURE OF THE HM CASSETTE TO ASPIRATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1