BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVIA CENTAUR XP

    MDR report key: 2342223 · Received November 18, 2011

    Report

    Report Number
    2432235-2011-00183
    Event Type
    Injury
    Date Received
    November 18, 2011
    Date of Event
    November 11, 2011
    Report Date
    November 14, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K971418
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SIEMENS FIELD SERVICE ENGINEER (FSE) WAS IN THE CONTROLLER DIAGNOSTICS PROGRAM PERFORMING A DIAGNOSTIC TEST, WHEN THE PROBE MOVED DOWN AND PUNCTURED THE GLOVED RING FINGER OF HIS LEFT HAND. THE SERVICE GUIDE PROVIDES WARNINGS IN THE AREA WHERE THE USE OF CONTROLLER DIAGNOSTICS IS DESCRIBED. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE SYSTEM IS REQUIRED.

    Description of Event or Problem · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS REPAIRING AN ADVIA CENTAUR XP INSTRUMENT. THE FSE WAS WEARING PERSONAL PROTECTIVE DEVICES, INCLUDING GLOVES, WHEN THE RING FINGER ON HIS LEFT HAND WAS PUNCTURED BY THE REAGENT PROBE. THE FSE RINSED AND WASHED THE AREA WELL WITH SOAP AND WATER, AND HE THEN WENT TO A NEARBY HOSPITAL'S ER, WHERE THE WOUND WAS CLEANSED AND SPRAYED WITH ANTIMICROBIAL AGENTS. HE WAS STARTED ON (AND WILL CONTINUE) A COURSE OF ORAL ANTIVIRAL MEDICATION (ATRIPIA). A TETANUS SHOT WAS ADMINISTERED, AND HIS BLOOD WAS DRAWN TO ASSESS LIVER FUNCTION THE FSE WILL HAVE BLOOD DRAWN DURING THE FOLLOWING YEAR TO MONITOR HIS HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR XP CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR XP

    Patients

    Seq Age Sex Outcome Treatment
    1 Other