BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIMENSION® CLINICAL CHEMISTRY SYSTEM

    MDR report key: 1812564 · Received August 24, 2010

    Report

    Report Number
    1226181-2010-00114
    Event Type
    Injury
    Date Received
    August 24, 2010
    Date of Event
    July 31, 2010
    Report Date
    July 31, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K010061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE OF THE STUCK FINGER BY THE SAMPLE PROBE WAS USER ERROR. THE OPERATOR DID NOT PLACE THE INSTRUMENT IN STANDBY BEFORE TRYING TO REMOVE THE CUP.THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS.NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    AN OPERATOR WAS REMOVING AN SSC AND WAS STUCK ON THE FINGER BY THE SAMPLE PROBE. THE OPERATOR RECEIVED A TETANUS SHOT AND IS RECEIVING TRIPLE THERAPY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention