BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION CLINICAL CHEMISTRY SYSTEM

    MDR report key: 1000733 · Received February 19, 2008

    Report

    Report Number
    1226181-2008-00015
    Event Type
    Malfunction
    Date Received
    February 19, 2008
    Date of Event
    January 21, 2008
    Report Date
    January 21, 2008
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSITICS INC.
    Product Code
    MMI
    PMA / PMN Number
    K010061
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 AN OVERACTIVE R2 TRANSDUCER. 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 1.28 NG/ML WAS OBTAINED ON A PT SAMPLE. THE RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAMPLE WAS RETESTED AND RESULT OF 0.02 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 AN OVERACTIVE R2 TRANSDUCER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1