BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARLIMS CLINICAL SOLUTION

    MDR report key: 7319854 · Received March 7, 2018

    Report

    Report Number
    3006130047-2018-00002
    Event Type
    Malfunction
    Date Received
    March 7, 2018
    Date of Event
    February 5, 2018
    Report Date
    March 6, 2018
    Manufacturer
    ABBOTT INFORMATICS CORPORATION
    Product Code
    JQP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE INVESTIGATION, IT WAS DISCOVERED THAT A TRANSMISSION ERROR OCCURRED BETWEEN THE INSTRUMENT AND THE CUSTOM MIDDLE WARE. MORE SPECIFICALLY, TWO MESSAGES WERE COMBINED DUE TO TRANSMISSION ERRORS THAT HAPPENED IN THE SEGMENTS IN BETWEEN. THE FIRST CCXML (MIDDLEWARE MESSAGE) WAS GENERATED BY THE FIRST COMPLETE RESULT DATA MESSAGE IN THE FIRST PACKET. THE SECOND CCXML WAS CONSTRUCTED WITH THE REMAINING PART IN THE FIRST PACKET, WHICH IS A PARTIAL MESSAGE. THE SECOND PART OF THE PARTIAL MESSAGE IS IN #3936. AFTER THAT, ALL REMAINING SEGMENTS OF #3936 WERE DROPPED. WHEN RESUMED WITH #3943, THE MESSAGE BEGAN RIGHT AWAY WITHOUT <STX>, PROBABLY MISLED THE MIDDLEWARE THAT IT WAS A CONTINUING PART FOR THE PREVIOUS RECEIVED CONTENT. AS A RESULT, THE MIDDLEWARE TREATED THE MESSAGE AS PART OF RESULT DATA AND COMBINED WITH PREVIOUS RECEIVED CONTENTS. THIS WAS CAUSED BY THE USER'S NETWORK WHICH HAD A FAILURE WHICH IN TURN CAUSED THE CORRUPTION OF THE DATA TRANSMISSION BETWEEN THE INSTRUMENT TO THE CUSTOM MIDDLEWARE AND THEN TO STARLIMS CLINICAL SOLUTION. THE MIDDLE WARE DID NOT DETECT THE NETWORK FAILURE AND PASSED THE WRONG RESULTS TO STARLIMS CLINICAL SOLUTION. THE CUSTOMER CORRECTED THE DATA AND RE-SENT THE REPORTS. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THIS ISSUE.

    Description of Event or Problem · 1

    STARLIMS CLINICAL SOLUTION IS A SOFTWARE SOLUTION FOR MANAGING RESEARCH AND DIAGNOSTIC LABORATORY DATA AND PROCESSES AND IS INTENDED TO BE USED BY TRAINED HEALTHCARE AND RESEARCH LABORATORY PROFESSIONALS. THE APPLICATION PROVIDES SINGLE AND MULTIPLE SITE FACILITIES THE ABILITY TO MANAGE PATIENT AND SAMPLE REGISTRATION, PRE-ANALYTICAL PROCESSING, MANUAL ENTRY OF INFORMATION AND COLLECTION OF DATA FROM IVD ANALYZERS AND/OR NON-DIAGNOSTICS INSTRUMENTS, DATA VALIDATION (TECHNICAL AND/OR CLINICAL) AND RESULT REPORTING. A CUSTOMER NOTIFIED ABBOTT INFORMATICS THAT OUR DEVICE WAS INVOLVED IN AN EVENT WHERE THERE WAS A DATA CORRUPTION DURING THE TRANSMISSION OF DATA RECEIVED FROM INSTRUMENT (OLYMPUS AU480 CLINICAL CHEMISTRY ANALYZER) TO A CUSTOM MIDDLE WARE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165424 STARLIMS CLINICAL SOLUTION CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE JQP ABBOTT INFORMATICS CORPORATION CL 10.06

    Patients

    Seq Age Sex Outcome Treatment
    1