BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIMENSION® CLINICAL CHEMISTRY SYSTEM

    MDR report key: 2170486 · Received July 21, 2011

    Report

    Report Number
    1226181-2011-00050
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    July 3, 2011
    Report Date
    July 3, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K963498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RUNNING WITH KEY SWITCH IN THE INTERRUPT OVERRIDE POSITION WHICH IS NON-STANDARD OPERATION WHEN THE INJURY OCCURRED. THE DIMENSION RXL MAX OPERATOR'S GUIDE STATES: "ONLY TRAINED OPERATORS SHOULD USE THIS [INTERRUPT OVERRIDE] KEY SWITCH AND THEN ONLY AS DIRECTED IN THIS MANUAL". THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    OPERATOR WAS PERFORMING MAINTENANCE ON THE INSTRUMENT WHEN THE IMT PROBE PUNCTURED A SAMPLE CUP. WHILE TRYING TO REMOVE THE SAMPLE CUP, THE PROBE MOVED AND PUNCTURED THE OPERATOR'S HAND. OPERATOR WAS GIVEN AN ANTI-VIRAL COCKTAIL AND IS SEEING AN INFECTION CONTROL PHYSICIAN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other