BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR

    MDR report key: 1903594 · Received November 16, 2010

    Report

    Report Number
    2432235-2010-00168
    Event Type
    Malfunction
    Date Received
    November 16, 2010
    Date of Event
    November 4, 2010
    Report Date
    November 5, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K971418
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCORDANT TESTOSTERONE RESULT WAS DUE TO A INTERMITTENT MALFUNCTION WITH THE ACID 2-WAY VALVE AND THE ACID PUMP. THE INSTRUMENT WAS REPAIRED. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT ADVIA CENTAUR TESTOSTERONE RESULT WAS OBTAINED ON A PT SAMPLES. THE RESULT WAS REPORTED TO THE PHYSICIAN. UPON RETEST THE CORRECTED RESULT WAS REPORTED TO THE PHYSICIAN. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES OR PT INTERVENTION DUE TO THE DISCORDANT TESTOSTERONE RESULT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1