BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR

    MDR report key: 2946376 · Received February 6, 2013

    Report

    Report Number
    2432235-2013-00043
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 14, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K971418
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE. AFTER ANALYZING THE INSTRUMENT AND THE INSTRUMENT DATA, THE FSE DETERMINED THAT THE CAUSE OF THE EVENT WAS A MALFUNCTION OF THE ACID PUMP. THE FSE REMOVED AND REPLACED THE PUMP THEN RAN QUALITY CONTROLS. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT RESULTS ON MULTIPLE ASSAYS WERE GENERATED BY THE ADVIA CENTAUR SYSTEM. THE SYSTEM DISPLAYED SIGNAL ERRORS WHICH ALERT THE USER TO INSTRUMENT ISSUES. THE RESULTS WERE RELEASED FROM THE LABORATORY. THE CUSTOMER RETESTED THE SAMPLES ON THE SAME INSTRUMENT AND OBTAINED RESULTS WITHIN EXPECTATIONS. CORRECTED REPORTS WERE ISSUED. THERE WERE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES OR KNOWN PATIENT INTERVENTION DUE TO THE DISCORDANT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50527 ADVIA CENTAUR IMMUNOASSAY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR

    Patients

    Seq Age Sex Outcome Treatment
    1