BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR

    MDR report key: 2192718 · Received August 5, 2011

    Report

    Report Number
    2432235-2011-00091
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 5, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K971418
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER(FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE ANALYZED THE INSTRUMENT AND FOUND THAT THE CUVETTE RING SPRING WAS BROKEN ON THE INSTRUMENT. THE FSE REPAIRED THE INSTRUMENT, CALIBRATED AND RAN QC. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT ADVIA CENTAUR -HUMAN CHORIONIC GONADOTROPIN (HCG) RESULT WAS OBTAINED ON ONE PATIENT SAMPLE. THE PATIENT SAMPLE WAS REPEATED ON ANOTHER SYSTEM AND THE CORRECTED RESULT WAS REPORTED. THERE WERE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES OR KNOWN PATIENT INTERVENTION DUE TO THE DISCORDANT HCG RESULTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1