BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION CLINICAL CHEMISTRY SYSTEM

    MDR report key: 1030165 · Received April 11, 2008

    Report

    Report Number
    1226181-2008-00036
    Event Type
    Malfunction
    Date Received
    April 11, 2008
    Date of Event
    March 31, 2008
    Report Date
    March 31, 2008
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    JJE
    PMA / PMN Number
    K944093
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER EVAL OF THE DEVICE IS REQUIRED. THE CAUSE OF THE FINGER STICK BY THE PROBE IS USER ERROR. THE OPERATOR WAS OPERATING THE INSTRUMENT WITH THE LID UP AND THE SWITCH IN BYPASS, THUS BYPASSING INSTRUMENT SAFETY MECHANISMS TO PREVENT ACCIDENTAL STICKS BY PROBES. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    AN INSTRUMENT OPERATOR WAS STUCK ON THE FINGER WITH THE INSTRUMENT IMT PROBE. THE OPERATOR WAS TREATED IN THE EMERGENCY DEPT AND IS RECEIVING ANTI VIRAL THERAPY. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSELY ELEVATED TROPONIN I RESULT. THE CAUSE OF THE FINGER STICK BY THE PROBE IS USER ERROR. THE OPERATOR WAS OPERATING THE INSTRUMENT WITH THE LID UP AND THE SWITCH IN BYPASS, THUS BYPASSING INSTRUMENT SAFETY MECHANISMS TO PREVENT ACCIDENTAL STICKS BY PROBES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1