BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION CLINICAL CHEMISTRY SYSTEM

    MDR report key: 1061750 · Received June 13, 2008

    Report

    Report Number
    2517506-2008-00052
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    May 19, 2008
    Report Date
    May 19, 2008
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MMI
    PMA / PMN Number
    K946153
    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 EVAL OF THE DEVICE IS REQUIRED. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE FALSELY ELEVATED TROPONIN I RESULT IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    A FALSELY ELEVATED TROPONIN I RESULT OF 7.71 NG/ML WAS OBTAINED ON A PT SAMPLE. THIS RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. A NEW SAMPLE WAS TESTED AND A RESULT OF 0.04 NG/ML 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 RESULT. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE FALSELY ELEVATED TROPONIN I RESULT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIMENSION CLINICAL CHEMISTRY SYSTEM CTNI FLEX REAGENT CARTRIDGE MMI SIEMENS HEALTHCARE DIAGNOSTICS, INC. NA FA9076

    Patients

    Seq Age Sex Outcome Treatment
    1