BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JRESULTNET

    MDR report key: 4250760 · Received October 23, 2014

    Report

    Report Number
    3007289202-2014-00002
    Event Type
    Malfunction
    Date Received
    October 23, 2014
    Report Date
    July 31, 2014
    Manufacturer
    DATA INNOVATIONS LLC
    Product Code
    JQP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    UNDER VERY SPECIFIC AND UNIQUE CIRCUMSTANCES, RESULTS FROM ONE PATIENT COULD BE ADDED TO A DIFFERENT PATIENT, LEADING TO A MISMATCH OF RESULTS FOR A GIVEN PATIENT. THIS IS DUE TO A HIGH LEVEL PROTOCOL (HLP) ISSUE IN JRESULTNET THAT AFFECTS THE MANNER IN WHICH NON TEST - LEVEL FIELD DATA IN THE RESULT (R) RECORD IS PARSED. THIS ONLY AFFECTS CERTAIN DRIVERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674688 JRESULTNET CALCULATOR/DATA PROCESSING MODULE JQP DATA INNOVATIONS LLC JRESULTNET

    Patients

    Seq Age Sex Outcome Treatment
    1