BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARLIMS CLINICAL SOLUTION

    MDR report key: 6086805 · Received November 8, 2016

    Report

    Report Number
    3006130047-2016-00016
    Event Type
    Malfunction
    Date Received
    November 8, 2016
    Date of Event
    October 28, 2016
    Report Date
    November 8, 2016
    Manufacturer
    ABBOTT INFORMATICS CORPORATION
    Product Code
    JQP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE INVESTIGATION IT WAS DISCOVERED THAT AN INFRASTRUCTURE ISSUE WAS IMPACTING THE PROCESSING OF HL7 ELECTRONIC MEDICAL RECORDS RESULTING IN THE BACK-UP OF REPORTS FOR DELIVERY. THE HL7 PROCESSING WAS TEMPORARILY SUSPENDED ALLOWING ALL PATIENT REPORTS TO BE DELIVERED WITHIN 24 HOURS. WHEN THE DELIVERY OF THE REPORTS WERE CAUGHT UP, HL7 PROCESSING WAS RESUMED AND COMPLETED WITHIN THE 24 HOUR PERIOD. THE ISSUE IS LIMITED TO THIS CUSTOMER DUE TO CUSTOMER SPECIFIC CONFIGURATION. 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 THE REPORTING DELIVERY QUEUE WAS BACKED UP WITH PATIENT RESULTS REPORTS AWAITING DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736174 STARLIMS CLINICAL SOLUTION CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE, PRODUCT CODE: JQP JQP ABBOTT INFORMATICS CORPORATION CL10.07

    Patients

    Seq Age Sex Outcome Treatment
    1