BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIMENSION® CLINICAL CHEMISTRY SYSTEM

    MDR report key: 1949528 · Received January 5, 2011

    Report

    Report Number
    1226181-2010-00166
    Event Type
    Injury
    Date Received
    January 5, 2011
    Date of Event
    December 14, 2010
    Report Date
    December 14, 2010
    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
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE OF THE STUCK FINGER BY THE SAMPLE PROBE WAS USER ERROR. THE OPERATOR DID NOT FOLLOW INSTRUCTIONS FOR OPERATION IN THAT AREA OF INSTRUMENT. THE INSTRUMENT WAS BEING USED WITH THE OVERRIDE SWITCH ON, CONTRARY TO INSTRUMENT WARNING ICONS AND STANDARD USE INSTRUCTIONS. BEST PRACTICE IS FOR THE OPERATOR TO "PAUSE" OR "STOP" THE INSTRUMENT AND PERFORM A CONTROLLED SHUTDOWN PRIOR TO PERFORMING OPERATION IN THIS AREA OF THE INSTRUMENT. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    AN OPERATOR WAS PERFORMING NON-STANDARD OPERATIONS WITHIN THE INSTRUMENT AND WAS STUCK THROUGH THE FINGER BY THE SAMPLE PROBE. THE OPERATOR RECEIVED STITCHES.

    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 RXLMAXHM

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention