BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR

    MDR report key: 2060415 · Received April 16, 2011

    Report

    Report Number
    2432235-2011-00054
    Event Type
    Malfunction
    Date Received
    April 16, 2011
    Date of Event
    March 4, 2011
    Report Date
    March 16, 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
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. AFTER ANALYZING THE INSTRUMENT DATA, THE FSE DETERMINED THAT THE CAUSE OF THE DISCORDANT THCG RESULTS WAS DUE TO A MALFUNCTION OF THE STAT SIDE RACK LOADING MECHANISM. THE FSE REPAIRED THE RACK LOADING MECHANISM. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    TWO DISCORDANT THCG RESULTS WERE OBTAINED ON AN ADVIA CENTAUR INSTRUMENT. INCORRECT RESULTS WERE REPORTED TO THE PHYSICIAN. THE SAMPLES WERE RE-RUN AND CORRECTED RESULTS WERE REPORTED. THERE WERE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES OR KNOWN PATIENT INTERVENTION.

    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