BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARLIMS PUBLIC HEALTH SOLUTION

    MDR report key: 5739963 · Received June 21, 2016

    Report

    Report Number
    3006130047-2016-00006
    Event Type
    Malfunction
    Date Received
    June 21, 2016
    Date of Event
    April 25, 2016
    Report Date
    July 22, 2016
    Manufacturer
    ABBOTT INFORMATICS CORPORATION
    Product Code
    JQP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ABBOTT INFORMATICS EVALUATED AND CONFIRMED THE ISSUE WAS REPRODUCIBLE. UPON FURTHER INVESTIGATION, IT WAS DETERMINED THAT THIS ISSUE IS DUE TO THE INTERACTION WITH ADOBE WHERE THE ACRRD32.EXXE PROCESS IS CONSTANTLY RUNNING. SETTINGS WERE REVIEWED AND THE ENHANCED SECURITY SETTING WAS DISABLE. ENHANCED SECURITY SETTINGS IN ADOBE WAS SET TO ENABLE. THIS HAS CORRECTED THIS EVENT. NO ADDITIONAL HANG FAILURES HAVE BEEN REPORTED. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THIS ISSUE.

    Additional Manufacturer Narrative · 1

    THE INITIAL REPORT OUGHT TO HAVE BEEN 06/21/2016, THE DATE THE MDR WAS SUBMITTED.

    Description of Event or Problem · 1

    STARLIMS PUBLIC HEALTH SOLUTION IS INTENDED FOR USE BY PUBLIC HEALTH LABORATORY PROFESSIONALS AND IT IS DESIGNED TO RECEIVE AND PROCESS SAMPLES FROM CLINICAL, CULTURE, ENVIRONMENTAL, FOOD AND OTHER AD-HOC OR PLANNED SAMPLE SUBMISSIONS. THE APPLICATION PROVIDES SINGLE AND MULTIPLE SITE FACILITIES, THE ABILITY TO STORE, RETRIEVE, PROCESS AND MANAGE THE DATA ASSOCIATED WITH SPECIMEN TESTING INCLUDING BUT NOT LIMITED TO PATIENT DEMOGRAPHICS, TESTS ORDERED, TEST RESULTS, TEST RESULT INTERPRETATION, QUALITY CONTROL RESULTS, AND RESULT CODES (FLAGS) THAT MAY BE ASSOCIATED WITH THE SPECIMEN FROM ITS ENTRY INTO THE LABORATORY WORKFLOW UNTIL THE REPORT (INCLUDING PATIENT REPORT) IS GENERATED AND RELEASED. SAMPLE INFORMATION MAY ALSO BE RETAINED AND USED FOR EPIDEMIOLOGICAL STUDIES OR SUBMISSION TO ADJUNCT AGENCIES SUCH AS GOVERNMENTAL PUBLIC HEALTH ORGANIZATIONS. WHEN THE SOFTWARE IS DEPLOYED, CONFIGURABLE SETTINGS ARE PROGRAMMED BASED ON THE CUSTOMER PREFERENCES. FOR INSTANCE, EACH LABORATORY ENTERS THEIR SPECIFIC POPULATION BASED REFERENCE RANGES THAT ARE USED TO EVALUATE IF A PATIENT'S TEST RESULTS ARE NORMAL, BELOW OR ABOVE THE REFERENCE RANGE AND REQUIRE FURTHER ACTION SUCH AS REPEAT TESTING. EACH LABORATORY ENTERS THEIR SPECIFIC REPORTING RULES FOR REPORTING SAMPLES THROUGH VARIOUS ELECTRONIC INTERFACES. A CUSTOMER NOTIFIED ABBOTT INFORMATICS THAT THE TUBERCULOSIS (TB)-PRELIMINARY RELEASE BY PANEL TAKES TOO LONG TO COMPILE, THAT IT TIMES OUT. USERS HAVE TO FORCE REPORTS OUT MULTIPLE TIMES. THE REPORTS ALSO GO TO REPORT DELIVERY QUEUE (RDQ) ERROR LOG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394523 STARLIMS PUBLIC HEALTH SOLUTION CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE JQP ABBOTT INFORMATICS CORPORATION PH 10.06

    Patients

    Seq Age Sex Outcome Treatment
    1