BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTRUMENT MANAGER SOFTWARE

    MDR report key: 11802500 · Received May 10, 2021

    Report

    Report Number
    1225673-2021-00008
    Event Type
    Malfunction
    Date Received
    May 10, 2021
    Date of Event
    April 12, 2021
    Report Date
    May 10, 2021
    Manufacturer
    DATA INNOVATIONS LLC
    Product Code
    JQP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A LABORATORY USER REPORTED ON (B)(6) 2021 THAT A RESULT HAD ALL ELECTROLYTES FLAGGED AS CRITICAL. THE RESULT WAS CAUGHT IN THE LABORATORY AND CORRECTED BEFORE IT WAS RELEASED TO THE LABORATORY INFORMATION SYSTEM (LIS). DUE TO INSUFFICIENT EVIDENCE AND THE INABILITY TO REPRODUCE THE ISSUE, DATA INNOVATIONS TECHNICAL SUPPORT AND THE CUSTOMER ARE UNABLE TO DETERMINE IF THIS IS A MALFUNCTION OF THE INSTRUMENT MANAGER SOFTWARE. THE INVESTIGATION IS ONGOING AT THIS TIME. THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    699500 INSTRUMENT MANAGER SOFTWARE CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE JQP DATA INNOVATIONS LLC 8.17.10

    Patients

    Seq Age Sex Outcome Treatment
    1