BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVIA 1200

    MDR report key: 2140272 · Received June 26, 2011

    Report

    Report Number
    2432235-2011-00096
    Event Type
    Injury
    Date Received
    June 26, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 20, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    JJE
    PMA / PMN Number
    K990346
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED BY CUSTOMER. INCIDENT IS UNDER INVESTIGATION.

    Description of Event or Problem · 1

    AN OPERATOR WAS PERFORMING MAINTENANCE ON AND ADVIA 1200 WHILE THE SYSTEM WAS STILL OPERATING AND THE RPP2 PROBE STRUCK THE OPERATOR'S HAND AND PIERCED THE GLOVE AND SKIN. THE OPERATOR WAS TREATED. THE CUSTOMER WOULD NOT PROVIDE ANY FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA 1200 CHEMISTRY ANALYZER, PRODUCT CODE: JJE JJE SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA 1200

    Patients

    Seq Age Sex Outcome Treatment
    1