BEUDAMED
    FDA Adverse Event Summary report: N

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

    MDR report key: 2494587 · Received March 16, 2012

    Report

    Report Number
    2243471-2012-00015
    Date Received
    March 16, 2012
    Date of Event
    February 7, 2012
    Report Date
    February 8, 2012
    Manufacturer
    ROCHE MOLECULAR SYSTEMS
    Product Code
    JJF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT CODE: SOFTWARE TIMING PROBLEM; CONCLUSION CODE: SOFTWARE / FIRMWARE CONTRIBUTED TO EVENT. THE AMPLILINK TRACE LOG FILE WAS NOT AVAILABLE FOR INVESTIGATION. THE INITIAL INVESTIGATION OF THE CUSTOMER'S LIS TRACE FILES INDICATE THAT NO REPORT TYPE WAS 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 WOULD HAVE CAUSED ORDERS TO BE REJECTED BY AL, AS THE ORDERS COULD NOT BE INTERPRETED. WHEN A REJECTED ORDER IS SENT TO THE LIS FROM AL, BUT THAT REJECTED ORDER IS NOT HANDLED PROPERLY BY THE LIS, IT IS POSSIBLE THAT THE LIS ASSIGNS INCORRECT RESULTS TO AN ORDER. IN THIS PARTICULAR CASE, IT IS POSSIBLE THAT A SOFTWARE CONCURRENCY ISSUE OCCURRED. AT THE SAME MOMENT WHEN A REJECTED ORDER WAS SENT TO THE LIS, A RESULT WAS ALSO SENT TO THE LIS. THESE TWO ASTM RECORDS COULD HAVE BEEN MIXED UP. THIS IS LIKELY TO HAVE OCCURRED, BUT CANNOT BE CONFIRMED WITHOUT REVIEWING THE AL 3.2 TRACE FILES, WHICH ARE NOT AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER IN THE US FILED A COMPLAINT ALLEGING THAT A (B)(6) CONTROL RESULT FROM THE CAP/CTM (B)(6) V2 TEST WAS TRANSFERRED TO THEIR LABORATORY INFORMATION SYSTEM (LIS) FROM AMPLILINK SOFTWARE V. 3.2.3 WITH A PATIENT RESULT RECORD. THE CUSTOMER PERFORMED A RUN OF 12 PATIENT SAMPLES. THEY STATE THAT IN THEIR LIS, THERE WAS A 13TH PATIENT SAMPLE WITH RESULTS. THEY DETERMINED THAT THE 13TH RESULT WAS ACTUALLY THE RESULT FROM THE (B)(6) CONTROL. THE RESULT WAS NOT REPORTED TO PHYSICIANS.

    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