BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTRUMENT MANAGER SOFTWARE

    MDR report key: 11711545 · Received April 22, 2021

    Report

    Report Number
    1225673-2021-00006
    Event Type
    Malfunction
    Date Received
    April 22, 2021
    Date of Event
    March 24, 2021
    Report Date
    April 22, 2021
    Manufacturer
    DATA INNOVATIONS LLC
    Product Code
    JQP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A LABORATORY USER REPORTED ON 24 MARCH 2021 THAT A VALUE FOR A1C WAS SENT TO THE LABORATORY INFORMATION SYSTEM (LIS) AS '<4.0' WHEN '8.1' WAS THE OBSERVED VALUE ON THE INSTRUMENT. INITIAL INVESTIGATION OF THE DATA INNOVATIONS INSTRUMENT MANAGER SPECIMEN MANAGEMENT MODULE EVENT LOG WAS UNABLE TO DETERMINE WHAT TRIGGERED A CONFIGURATION VALUE AND IF THE RESULT WAS CHANGED BY INSTRUMENT MANAGER. THERE WAS NO PATIENT HARM AS THIS WAS A ONE-TIME OCCURRENCE AND THE TECHNOLOGIST RECOGNIZED THE PROBLEM BEFORE THE PATIENT RESULTS WERE VERIFIED AND SENT TO THE PATIENT'S MEDICAL RECORD. THE INVESTIGATION HAS BEEN UNABLE TO REPRODUCE THE ISSUE AND THEREFORE, IT HAS NOT YET BEEN DETERMINED IF THIS IS A MALFUNCTION OF THE INSTRUMENT MANAGER SOFTWARE. THE INVESTIGATION IS ONGOING AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607622 INSTRUMENT MANAGER SOFTWARE CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE JQP DATA INNOVATIONS LLC 8.13.01

    Patients

    Seq Age Sex Outcome Treatment
    1