BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSTRUMENT MANAGER SOFTWARE

    MDR report key: 7857180 · Received September 7, 2018

    Report

    Report Number
    1225673-2018-00009
    Event Type
    Injury
    Date Received
    September 7, 2018
    Report Date
    September 7, 2018
    Manufacturer
    DATA INNOVATIONS LLC
    Product Code
    JQP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER HAD AN INCORRECTLY WRITTEN RULE (CONFIGURATION) WHICH WAS CHANGING A RESULT OF >5000 TO <10. THE RULE DID NOT CONTAIN AN "IS NUMERIC" OPERATOR, SO WHEN A RESULT IS RECEIVED WITH THE ">", IT CAUSES THE RULE TO FAIL. THIS IS NOT A DEVICE MALFUNCTION, IT IS AN INCORRECT CONFIGURATION BY THE USER. DUE TO THE CHANGED RESULT BEING VERY FAR OUT OF RANGE, THIS WAS CAUGHT BY A LAB TECHNICIAN PRIOR TO BEING POSTED TO A PATIENTS CHART. THE LAB TECHNICIANS ARE MONITORING EACH RESULT WHILE THE RULE IS BEING CORRECTED TO CATCH ANY ERRONEOUS RESULTS. THE CUSTOMER IS CONTINUING TO INVESTIGATE PREVIOUS RESULTS FROM OTHER PATIENTS WHERE THIS CONFIGURATION WAS PRESENT TO DETERMINE IF ANY PATIENTS WERE HARMED. AT THIS TIME, THERE IS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    699226 INSTRUMENT MANAGER SOFTWARE CALCULATOR/DATA PROCESSING MODULE FOR CLINICAL USE JQP DATA INNOVATIONS LLC V8.14.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other