BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARLIMS PUBLIC HEALTH SOLUTION

    MDR report key: 6048502 · Received October 21, 2016

    Report

    Report Number
    3006130047-2016-00013
    Event Type
    Malfunction
    Date Received
    October 21, 2016
    Date of Event
    September 21, 2016
    Report Date
    October 21, 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

    THE ISSUE WAS REVIEWED BY ABBOTT INFORMATICS (AI) CUSTOMER SERVICE AND CORRECTED. THE ROOT CAUSE WAS AN ISSUE WITH THE INCOMING HL7 INTERFACE. 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 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 A REPORT WAS NOT DELIVERED TO THEIR CUSTOMER VIA THE HL7 INTERFACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697970 STARLIMS PUBLIC HEALTH SOLUTION CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE JQP ABBOTT INFORMATICS CORPORATION PH 10.03

    Patients

    Seq Age Sex Outcome Treatment
    1