BEUDAMED
    FDA Adverse Event Summary report: N

    AMPLILINK SOFTWARE V3.2.3 WITH CAP/CTM AND COBAS AMPLICOR

    MDR report key: 2494628 · Received March 16, 2012

    Report

    Report Number
    2243471-2012-00013
    Date Received
    March 16, 2012
    Date of Event
    February 16, 2012
    Report Date
    February 17, 2012
    Manufacturer
    ROCHE MOLECULAR SYSTEMS
    Product Code
    JJF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION DETERMINED THAT INCORRECT TEST IDS WERE BEING SENT IN THE ASTM TRANSMISSION FROM THE CUSTOMER'S LABORATORY INFORMATION SYSTEM (LIS) TO AMPLILINK (AL) SOFTWARE VERSION 3.2.3. THIS FORMAT DOES NOT FOLLOW THE ASTM PROTOCOL DEFINITIONS PROVIDED IN THE AMPLILINK 3.2 HOST INTERFACE MANUAL. THIS CAUSED ORDERS TO BE REJECTED BY AL, AS THE ORDERS COULD NOT BE INTERPRETED. THE AMPLILINK TRACE FILES SHOWED THAT THE REJECTED ORDER WAS SENT TO THE LIS BUT THAT REJECTED ORDER WAS NOT HANDLED PROPERLY BY THE LIS. IF THE ORDER HAD BEEN SENT IN THE CORRECT FORMAT FROM THE LIS, THE ISSUE WOULD NOT HAVE OCCURRED. IN THIS PARTICULAR COMPLAINT CASE, A SOFTWARE CONCURRENCY ISSUE WAS OBSERVED. AT THE SAME MOMENT WHEN THE REJECTED ORDER WAS SENT TO LIS, A RESULT WAS ALSO SENT TO LIS. THESE TWO ASTM RECORDS WERE MIXED UP, AND THE RESULT OF SAMPLE (B)(4) WAS APPENDED TO THE REJECTED ORDER ID (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER FROM (B)(6) REPORTED THAT RESULTS FOR TESTS THAT HAD BEEN PREVIOUSLY PROCESSED WERE INCLUDED ON ORDERS SENT FROM THEIR LIS TO THE AMPLILINK (AL) SOFTWARE V.3.2.3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLILINK SOFTWARE V3.2.3 WITH CAP/CTM AND COBAS AMPLICOR USER INTERFACE AND DATA MANAGEMENT SOFTWARE FOR USE WITH AUTOMATED PCR INSTRUMEN JJF ROCHE MOLECULAR SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1