BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIMENSION® CLINICAL CHEMISTRY SYSTEM

    MDR report key: 2063315 · Received April 19, 2011

    Report

    Report Number
    1226181-2011-00034
    Event Type
    Injury
    Date Received
    April 19, 2011
    Date of Event
    March 24, 2011
    Report Date
    April 6, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC- BROOKFIELD
    Product Code
    JJE
    PMA / PMN Number
    K944093
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE OF THE INJURY WAS OPERATOR INATTENTION. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A SIEMENS HEALTHCARE DIAGNOSITICS(R) FIELD SERVICE ENGINEER (FSE) WAS PERFORMING CORRECTIVE MAINTENANCE OPERATIONS ON THE DIMENSION(R) ANALYZER. WHILE PERFORMING REPAIRS, THE FSE PUNCTURED HIS FINGER WITH THE SAMPLE PROBE. NO STICHES WERE REQUIRED BUT THE OPERATOR UNDERWENT BIOHAZARD EXPOSURE WORKUP INCLUDING PROPHYLACTIC RETROVIRAL MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIMENSION® CLINICAL CHEMISTRY SYSTEM CLINICAL CHEMISTRY SYSTEM JJE SIEMENS HEALTHCARE DIAGNOSTICS INC- BROOKFIELD DIMENSION® /RXL MAX

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention