BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP

    MDR report key: 3914724 · Received July 3, 2014

    Report

    Report Number
    2432235-2014-00408
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 6, 2014
    Report Date
    June 10, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    CDZ
    PMA / PMN Number
    K971418
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. AFTER EVALUATION OF THE INSTRUMENT AND INSTRUMENT DATA, THE CSE DETERMINED THAT WASH 1 REAGENT WAS DRIPPING FROM THE WASH 1 RESUSPEND PORT INTO THE INCUBATION RING CUVETTES. THE CSE DETERMINED THAT THE RESUSPEND PORT TUBING WAS LEAKING. THE CAUSE OF THE PROGESTERONE AND TESTOSTERONE IMPRECISION WAS DUE TO A LEAKING RESUSPEND PORT TUBING. THE CSE REPLACED THE RESUSPEND TUBING AND SUCCESSFULLY RAN QC. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. FURTHER EVALUATION OF THE DEVICE IS NOT REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED PROGESTERONE AND TESTOSTERONE IMPRECISION ON AN ADVIA CENTAUR XP INSTRUMENT. THE CUSTOMER WAS NOT PROCESSING PATIENT SAMPLES DURING THE TIME WHEN PROGESTERONE AND TESTOSTERONE IMPRECISION OCCURRED. THERE WERE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES OR KNOWN PATIENT INTERVENTION DUE TO THE PROGESTERONE AND TESTOSTERONE IMPRECISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391891 ADVIA CENTAUR XP IMMUNOASSAY ANALYZER CDZ SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR XP

    Patients

    Seq Age Sex Outcome Treatment
    1