BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSACELL SAMPLE MANAGEMENT SYSTEM

    MDR report key: 3777093 · Received April 29, 2014

    Report

    Report Number
    2247117-2014-00024
    Event Type
    Malfunction
    Date Received
    April 29, 2014
    Date of Event
    May 31, 2013
    Report Date
    May 31, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    LXG
    PMA / PMN Number
    K970227
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR 2247117-2014-00024 WAS FILED ON APRIL 29TH, 2014. ADDITIONAL INFORMATION (06/02/2014): THERE IS AN INDICATION TO THE OPERATOR THAT THE SAMPLE IS NOT PROCESSING IN THE VERSACELL SOFTWARE IN CASES WHEN THE VERSACELL DOES NOT TRANSMIT THE TEST ORDER TO THE CONNECTED ANALYZER FOR FRONT LOADED TUBES. THE CUSTOMER SHOULD FOLLOW THE RECOMMENDATIONS PREVIOUSLY PROVIDED FOR THIS SITUATION. THE OPEN TEST ORDERS WILL APPEAR WITH A STATUS OF 'NO SAMPLE' AT THE VERSACELL LIS SCREEN. THE OPERATOR MAY SORT BY SAMPLE STATUS TO DETERMINE ANY OUTSTANDING ORDERS THAT MAY NEED TO BE PROCESSED. MDR 2247117-2014-00024 THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 1

    A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. AFTER EVALUATING THE VERSACELL SAMPLE MANAGEMENT SYSTEM AND DATA, THE CSE DETERMINED THAT WHEN THE CUSTOMER WAS FRONTLOADING A SAMPLE RACK ONTO THE ADVIA CENTAUR XP SYSTEM, A 'NO REQUEST' STATUS WAS OBTAINED AND THE SAMPLE RACK WAS EJECTED FROM THE ANALYZER. THE CSE DETERMINED THAT WHEN THE CUSTOMER RE-LOADED THE SAME SAMPLE RACK ON THE ADVIA CENTAUR XP SYSTEM, THE LABORATORY INFORMATION SYSTEM (LIS) ORDER WAS RECEIVED FROM THE HOST. THE CSE VERIFIED THAT THE VERSACELL LOG FILES SHOWED THE SAMPLE IN QUESTION WAS QUERIED TO THE LIS BY THE VERSACELL AND THE TEST ORDER FOR CARDIAC TROPONIN I (TNIU) WAS DOWNLOADED FROM THE LIS, HOWEVER, IT WAS NOT SENT TO THE ADVIA CENTAUR XP BY THE VERSACELL. THE CAUSE OF THE VERSACELL NOT SAVING TEST ORDERS FOR SAMPLES MANUALLY LOADED AT THE CONNECTED ANALYZER IS UNKNOWN. THE CSE INSTRUCTED THE CUSTOMER THAT IN CASES WHERE THE OPERATOR MUST MANUALLY FRONTLOAD A SAMPLE, THE OPERATOR SHOULD VERIFY THAT ALL TEST ORDERS ARE DOWNLOADED AS EXPECTED WHEN REMOVING AN EJECTED RACK FROM THE ADVIA CENTAUR XP SYSTEM. SIEMENS IS CURRENTLY INVESTIGATING THIS ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A CARDIAC TROPONIN I (TNIU) TEST FOR ONE PATIENT WAS NOT PROCESSED BECAUSE THE VERSACELL SYSTEM DID NOT SAVE THE TEST ORDER FOR SAMPLES THAT WERE MANUALLY LOADED ON THE CONNECTED ANALYZER (ADVIA CENTAUR XP SYSTEM). THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE VERSACELL SYSTEM NOT SAVING TEST ORDERS FOR SAMPLES THAT WERE MANUALLY LOADED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256634 VERSACELL SAMPLE MANAGEMENT SYSTEM GENERAL PURPOSE LABORATORY EQUIPMENT LXG SIEMENS HEALTHCARE DIAGNOSTICS INC. VERSACELL SAMPLE MANAGEMENT SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1