BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARLIMS CLINICAL SOLUTION

    MDR report key: 6767913 · Received August 4, 2017

    Report

    Report Number
    3006130047-2017-00003
    Event Type
    Malfunction
    Date Received
    August 4, 2017
    Date of Event
    July 6, 2017
    Report Date
    August 4, 2017
    Manufacturer
    ABBOTT INFORMATICS CORPORATION
    Product Code
    JQP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE INVESTIGATION IT WAS DISCOVERED THAT THE CLIENT'S IT DEPARTMENT ALTERED THE CRYSTAL REPORT TEMPLATES AND PRINTING SCRIPTS THAT CAUSED THE RESULTS TO BE SORTED IN THE WRONG ORDER WHICH THEN CAUSED THE ALGORITHM TO INCORRECTLY SHOW THE FINAL RESULT ON THE REPORT. THIS CHANGE ALSO CAUSED THE SYSTEM TO GROUP THE REPORTS INCORRECTLY AND SEVERAL REPORTS WERE DELIVERED TO THE WRONG HOSPITAL. WE HAVE BEEN IN CONSTANT COMMUNICATION WITH THE LAB AND THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THIS ISSUE AT THIS TIME.

    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 SOME (B)(6) RESULTS WERE TRANSLATED IN (B)(6) RESULTS AFTER THE INSTRUMENT INTERFACE WAS EXECUTED. THERE ALSO MENTION OF WRONG PATIENT INFORMATION AND DATA TRANSMITTED TO THE WRONG HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    549685 STARLIMS CLINICAL SOLUTION CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE JQP ABBOTT INFORMATICS CORPORATION CL 10.07

    Patients

    Seq Age Sex Outcome Treatment
    1