BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSACELL SAMPLE MANAGEMENT SYSTEM

    MDR report key: 3222547 · Received July 12, 2013

    Report

    Report Number
    2247117-2013-00068
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 16, 2013
    Report Date
    June 16, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    LXG
    PMA / PMN Number
    K023741
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. AFTER EVALUATION OF THE INSTRUMENT AND INSTRUMENT DATA, THE FSE DISCOVERED THE ADVIA CENTAUR INSTRUMENT PROBE PIERCED THE SAMPLE TUBE AND THE TUBE STUCK TO THE PROBE, THEN FELL. CUSTOMER STATED THE OPERATION OF THE INSTRUMENT WAS WITHOUT ERROR AFTER THIS INSTANCE. THE CAUSE OF THE DROPPED TUBE WAS DUE TO THE ADVIA CENTAUR XP PROBE GETTING STUCK TO THE TUBE. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A TUBE WAS PLACED ON THE VERSACELL SAMPLE MANAGEMENT SYSTEM AND WAS FOUND DROPPED BEHIND THE SAMPLE PROBE TIP REMOVER OF AN ADVIA CENTAUR INSTRUMENT. THE CUSTOMER WAS ABLE TO RETRIEVE THE SAMPLE TUBE AND USE THE SAMPLE, AS NO SAMPLE HAD SPILLED FROM THE TUBE. IT IS UNKNOWN IF ANY RESULTS WERE REPORTED TO THE PHYSICIAN(S) FOR THIS TUBE. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DROPPED TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322972 VERSACELL SAMPLE MANAGEMENT SYSTEM CLINICAL CHEMISTRY LXG SIEMENS HEALTHCARE DIAGNOSTICS INC. VERSACELL SAMPLE MANAGEMENT SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1