BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR XP

    MDR report key: 1193532 · Received October 8, 2008

    Report

    Report Number
    2432235-2008-00116
    Event Type
    Other
    Date Received
    October 8, 2008
    Date of Event
    September 11, 2008
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K971418
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE SITE. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCORDANT AND TNI ULTRA RESULTS, WAS DUE TO CRACK IN WASH 1 TUBING. THE INSTRUMENT HAS BEEN REPAIRED. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    FOUR REACTIVE ADVIA CENTAUR XP PT RESULTS WERE OBTAINED AND UPON REPEAT (IN DUPLICATE) ALL FOUR WERE NON-REACTIVE. THE REACTIVE RESULTS WERE NOT REPORTED TO THE PHYSICIAN. FIVE POSITIVE ADIVA CENTAUR XP TROPONIN ULTRA PT RESULTS WERE ALSO OBTAINED IN THE SAME TIME FRAME AS THE ABOVE SAMPLES AND UPON REPEAT ALL FIVE WERE NEGATIVE. THE POSITIVE RESULTS WERE NOT REPORTED TO THE PHYSICIAN. PT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEATH CONSEQUENCES, DUE TO THE DISCORDANT AND TNI ULTRA RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR XP IMMUNO-ASSAY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1