BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION CLINICAL CHEMISTRY SYSTEM

    MDR report key: 1213981 · Received October 24, 2008

    Report

    Report Number
    1226181-2008-00111
    Event Type
    Malfunction
    Date Received
    October 24, 2008
    Date of Event
    September 29, 2008
    Report Date
    September 29, 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
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS HEALTHCARE DIAGNOSTICS, INC FIELD SERVICE REPRESENTATIVE (FSE) WAS DISPATCHED TO THE ACCOUNT. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE FALSELY ELEVATED TROPONIN I RESULT WAS A SLIPPING HM CASSETTE. THE FSE CORRECTED THE MALFUNCTION. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    FALSELY ELEVATED TROPONIN I RESULTS WERE OBTAINED ON TWO PATIENT SAMPLES. THE RESULTS WERE REPORTED TO THE PHYSICIAN. THE SAMPLES WERE REPEATED AND NEGATIVE RESULTS WERE OBTAINED. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSELY ELEVATED TROPONIN I RESULTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1