BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR

    MDR report key: 3021974 · Received March 26, 2013

    Report

    Report Number
    2432235-2013-00104
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    February 27, 2013
    Report Date
    February 27, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K971418
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE CUSTOMER INFORMED THE FSE THAT THE LEAK WAS COMING FROM THE REAGENT PROBE 3 TUBING, WHICH THE CUSTOMER HAD REPLACED. THE FSE VERIFIED THAT TUBING HAD BEEN CHANGED CORRECTLY. THE FSE ALSO DISCOVERED THAT THE REAGENT COMPARTMENT LID NEEDED TO BE REPAIRED, WHICH THE FSE DID. THE FSE RAN QUALITY CONTROLS, ALL OF WHICH WERE WITHIN RANGE. THE CAUSE OF THE LEAK WAS A MALFUNCTION OF THE REAGENT PROBE TUBING. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    THE OPERATOR OF AN ADVIA CENTAUR INSTRUMENT DISCOVERED A LEAK WHILE THE INSTRUMENT WAS RUNNING PATIENT SAMPLES. THE OPERATOR STOPPED THE RUN AND POWERED DOWN THE INSTRUMENT. IT IS UNKNOWN WHAT ASSAY(S) WERE BEING TESTED. NO PATIENT RESULTS FROM THIS RUN WERE REPORTED OUT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE INSTRUMENT LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124154 ADVIA CENTAUR IMMUNOASSAY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS ADVIA CENTAUR

    Patients

    Seq Age Sex Outcome Treatment
    1