BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP

    MDR report key: 3093054 · Received May 3, 2013

    Report

    Report Number
    2432235-2013-00164
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    March 31, 2013
    Report Date
    April 3, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    LOM
    PMA / PMN Number
    K041133
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED A SIEMENS TECHNICAL SERVICE CONSULTANT REGARDING A (B)(6) PATIENT SAMPLE. THE TSC EVALUATED THE INSTRUMENT DATA AND DETERMINED CONTROLS WERE IN RANGE DURING THE EVENT AND THAT THE CAUSE OF THE (B)(6) PATIENT SAMPLE WAS USER ERROR; PRE-ANALYTICAL ISSUE. THE CUSTOMER DECLINED FURTHER SERVICE. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. FURTHER EVALUATION OF THE DEVICE IS NOT REQUIRED.

    Description of Event or Problem · 1

    A (B)(6) PATIENT SAMPLE WAS OBTAINED ON AN ADVIA CENTAUR XP INSTRUMENT. THE INITIAL RESULT WAS (B)(6) AND REPORTED TO THE PHYSICIAN. A NEW SAMPLE WAS DRAWN AND THE CORRECTED RESULT WAS REPORTED TO THE PHYSICIAN. THERE WERE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES OR KNOWN PATIENT INTERVENTION DUE TO THE INCORRECTLY REPORTED (B)(6) RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194506 ADVIA CENTAUR XP IMMUNOASSAY ANALYZER LOM SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR XP

    Patients

    Seq Age Sex Outcome Treatment
    1