BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTRUMENT MANAGER SOFTWARE

    MDR report key: 8768807 · Received July 8, 2019

    Report

    Report Number
    1225673-2019-00008
    Event Type
    Malfunction
    Date Received
    July 8, 2019
    Date of Event
    June 11, 2019
    Report Date
    July 8, 2019
    Manufacturer
    DATA INNOVATIONS LLC
    Product Code
    JQP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    DATA INNOVATIONS' (DI) CUSTOMER (B)(6) HOSPITAL AND CLINICS INC UPDATED AN INSTRUMENT (MYLA) IN THE LAB LATE IN THE DAY (B)(6) 2019. THE FOLLOWING MORNING AFTER THAT UPGRADE, INSTRUMENT MANAGER WAS NO LONGER SENDING RESULTS TO THE LABORATORY INFORMATION SYSTEM (LIS). IN TROUBLESHOOTING THE ISSUE WITH SHANDS, DI'S SUPPORT DEPARTMENT DISCOVERED THE DRIVER FOR THE MYLA (B)(4) HAS SOME CONFIGURATION PROPERTIES SET TO NULL WHICH WAS CAUSING THE RESULTS TO NOT PASS THROUGH THE SYSTEMS CORRECTLY. DATA INNOVATIONS HAS NOT BEEN ABLE TO RECREATE THE ISSUE, NOR DETERMINE HOW THE FIELDS BECAME NULL. IT IS NOT POSSIBLE FOR AN END USER TO CHANGE THE FIELDS TO NULL, AND DI HAS BEEN UNABLE TO DETERMINE HOW THIS OCCURRED, AND HAS NOT BEEN ABLE TO REPRODUCE IT. DI HAS NOT BEEN ABLE TO CONFIRM THIS IS AN INSTRUMENT MANAGER MALFUNCTION. THERE WAS NO PATIENT HARM AS A RESULT OF THIS ISSUE, THERE WAS A DELAY IN REPORTING RESULTS TO THE LIS. DI IS REPORTING THIS EVENT SINCE A ROOT CAUSE HAS NOT BEEN DETERMINED AND IT HAS NOT BEEN ESTABLISHED IF THIS WAS OR WAS NOT AN INSTRUMENT MANAGER MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563182 INSTRUMENT MANAGER SOFTWARE CALCULATOR/DATA PROCESSING MODULE FOR CLINICAL USE JQP DATA INNOVATIONS LLC V8.15.10

    Patients

    Seq Age Sex Outcome Treatment
    1