BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION CLINICAL CHEMISTRY SYSTEM

    MDR report key: 1033022 · Received April 22, 2008

    Report

    Report Number
    1226181-2008-00040
    Event Type
    Malfunction
    Date Received
    April 22, 2008
    Date of Event
    March 26, 2008
    Report Date
    March 26, 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
    GA, 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 CARRY IN FROM THE R1 PROBE. THE MALFUNCTION WAS RESOLVED AFTER THE CUSTOMER PERFORMED MAINTENANCE WITH GUIDANCE FROM A SIEMENS HEALTHCARE DIAGNOSTICS INC TECHNICAL SOLUTION CENTER REP. THE INSTRUMENT IS PERFORMING WITHIN SPECS.

    Description of Event or Problem · 1

    A FALSELY ELEVATED TROPONIN I RESULT OF 1.27 NG/ML WAS OBTAINED ON A PT SAMPLE. THE RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAMPLE WAS RETESTED AND A RESULT OF 0.04 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 OF THE FALSELY ELEVATED TROPONIN I RESULT WAS CARRYING FROM THE R1 PROBE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1