BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STREAMLAB ANALYTICAL WORKCELL

    MDR report key: 6067943 · Received October 31, 2016

    Report

    Report Number
    1226181-2016-00482
    Event Type
    Malfunction
    Date Received
    October 31, 2016
    Date of Event
    October 6, 2016
    Report Date
    January 7, 2017
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    LXG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR 1226181-2016-00482 WAS FILED ON OCTOBER 31, 2016. ADDITIONAL INFORMATION (12/14/2016): THE CUSTOMER IS OPERATIONAL. THERE HAS BEEN NO IMPACT ON PATIENTS DUE TO THE DELAY REPORTED. THE ISSUE WAS RESOLVED WITH A CONFIGURATION CHANGE ON THE DIMENSION INSTRUMENT SOFTWARE. THE CAUSE OF THE DELAY REPORTED WAS DUE TO A CONFIGURATION ISSUE. 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 EVALUATION OF THE INSTRUMENT, THE CSE CHANGED THE DIMENSION SOFTWARE "SCHEDULE TESTS" CONFIGURATION FROM "OPTIMIZE TIME/HM FIRST" TO "OPTIMIZE TIME TO RESULTS" TO FORCE THE ASPIRATION OF A WAITING SAMPLE. A SIEMENS HEADQUARTER SUPPORT CENTER (HSC) SPECIALIST REVIEWED THE INSTRUMENT DATA. THE SAMPLE IN QUESTION ((B)(6)) WAS LOCKED IN PLACE AND ALIQUOTED ON ONE ANALYZER THEN RELOADED BACK TO THE INPUT/OUTPUT MODULE AND PLACED IN AN OUTPUT RACK AT 9:37. THERE WAS NO ERROR ASSOCIATED WITH THIS SAMPLE ON THE AUTOMATION SYSTEM. THERE WAS A RE-RUN ORDERED AT 10:52 BUT IT WAS ROUTED TO ANOTHER ANALYZER. SIEMENS IS INVESTIGATING THIS ISSUE.

    Description of Event or Problem · 1

    DELAY IN RECEIVING PATIENT RESULTS WAS OBSERVED ON A STREAMLAB CORE UNIT INSTRUMENT. THE CUSTOMER PROVIDED AN EXAMPLE OF A PATIENT SAMPLE ((B)(6)) WHICH WAS PIPETTED AT 9:36 AND AT 10:53, AND THE RESULTS WERE RECEIVED AT 11:08 FROM A DIMENSION INSTRUMENT. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE EVENTS DUE THE DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719048 STREAMLAB ANALYTICAL WORKCELL STREAMLAB ANALYTICAL WORKCELL LXG SIEMENS HEALTHCARE DIAGNOSTICS INC STREAMLAB ANALYTICAL WORKCELL

    Patients

    Seq Age Sex Outcome Treatment
    1