BEUDAMED
    FDA Adverse Event Summary report: N

    ADVIA CENTAUR XP

    MDR report key: 2042735 · Received April 6, 2011

    Report

    Report Number
    2432235-2011-00051
    Date Received
    April 6, 2011
    Date of Event
    March 9, 2011
    Report Date
    March 14, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K971418
    Removal / Correction Number
    N/A
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER(FSE) WAS AT THE CUSTOMER SITE REPAIRING THE INSTRUMENT. THE SERVICE PERSON WAS NOT WEARING PERSONAL PROTECTIVE EQUIPMENT AS REQUIRED BY COMPANY POLICY. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A SERUM SAMPLE TUBE SPLASHED ON A SIEMENS SERVICE PERSON'S FACE ON AN ADVIA CENTAUR XP INSTRUMENT WHILE WORKING ON THE SYSTEM. THE SERVICE PERSON WAS TREATED ON-SITE AND IN THE EMERGENCY ROOM. THERE WERE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR XP IMMUNOASSAY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS ADVIA CENTAUR XP N/A

    Patients

    Seq Age Sex Outcome Treatment
    1