BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTRUMENT MANAGER SOFTWARE

    MDR report key: 8006806 · Received October 25, 2018

    Report

    Report Number
    1225673-2018-00010
    Event Type
    Malfunction
    Date Received
    October 25, 2018
    Report Date
    October 25, 2018
    Manufacturer
    DATA INNOVATIONS LLC
    Product Code
    JQP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    A CONFIGURATION RULE THAT WAS WRITTEN FOR ONE CONFIGURATION WAS IMPROPERLY COPIED TO A DIFFERENT CONFIGURATION BY THE USER. THIS CAUSED A ROUNDING ERROR WHEN PROCESSING TROPONIN RESULTS. TROPONIN RESULTS FROM 0.01 TO 0.49 WERE REPORTING AS LESS THAN 0.01. TROPONIN RESULTS FROM 0.5 TO 0.99 WERE CONVERTING TO 1.0. THIS WAS USER ERROR, NOT AN INSTRUMENT MANAGER MALFUNCTION. AT THIS TIME DATA INNOVATIONS HAS NO REPORT OF PATIENT OR USER HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    846223 INSTRUMENT MANAGER SOFTWARE CALCULATOR/DATA PROCESSING MODULE JQP DATA INNOVATIONS LLC V8.14.10

    Patients

    Seq Age Sex Outcome Treatment
    1