BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARLIMS CLINICAL SOLUTION

    MDR report key: 5926719 · Received September 2, 2016

    Report

    Report Number
    3006130047-2016-00012
    Event Type
    Malfunction
    Date Received
    September 2, 2016
    Date of Event
    August 4, 2016
    Report Date
    September 2, 2016
    Manufacturer
    ABBOTT INFORMATICS CORPORATION
    Product Code
    JQP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE INVESTIGATION THE CENTRAL RECEIVING TABLE SHOWED MULTIPLE UPDATES TO PATIENT DEMOGRAPHICS THAT HAVE BEEN DONE BOTH THROUGH THE ELECTRONIC KIPU INTERFACE AND MANUALLY BY THE CLIENT. THERE WAS NO PRODUCT MALFUNCTION, THE ISSUE WAS CAUSED BY THE CLIENT. 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 PATIENT DEMOGRAPHIC DATA HAD BEEN OVERWRITTEN WITH DIFFERENT PATIENT DEMOGRAPHIC DATA. MORE SPECIFICALLY, THE PATIENT'S LAST NAME, FIRST NAME, DATE OF BIRTH, AND GENDER WERE CHANGED AND THE DATE OF BIRTH WAS SET AS THE CURRENT DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578580 STARLIMS CLINICAL SOLUTION CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE JQP ABBOTT INFORMATICS CORPORATION CL10.07

    Patients

    Seq Age Sex Outcome Treatment
    1