BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION CLINICAL CHEMISTRY SYSTEM

    MDR report key: 1063857 · Received June 19, 2008

    Report

    Report Number
    1226181-2008-00065
    Event Type
    Malfunction
    Date Received
    June 19, 2008
    Date of Event
    May 24, 2008
    Report Date
    May 24, 2008
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K010061
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS HEALTHCARE DIAGNOSTICS INC FIELD SERVICE REP (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 R1 ARM AND DRAIN PROBLEMS CAUSING CARRY INTO THE CUVETTE. 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

    TWO FALSELY ELEVATED TROPONIN I RESULTS WERE OBTAINED ON A PT SAMPLE. THE RESULTS WERE NOT REPORTED TO THE PHYSICIAN. THE SAMPLE WAS REPEATED ON THE SAME ANALYZER AND A NEGATIVE RESULT WAS OBTAINED. PT 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 CLINICAL CHEMISTRY SYSTEM JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. XPANDHM NA

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR