BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTRUMENT MANAGER SOFTWARE

    MDR report key: 20035365 · Received August 22, 2024

    Report

    Report Number
    1225673-2024-00004
    Event Type
    Malfunction
    Date Received
    August 22, 2024
    Date of Event
    July 23, 2024
    Report Date
    August 21, 2024
    Manufacturer
    DATA INNOVATIONS LLC
    Product Code
    JQP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A COLLABORATIVE INVESTIGATION WAS COMPLETED BY DATA INNOVATIONS (MANUFACTURER), AND (B)(6) HOSPITAL (USER FACILITY). INVESTIGATION DETERMINED USER ERROR WHEN RELEASING THE RESULT. SINCE 0.0 WAS RELEASED FOR ALL ABSOLUTE VLAUES, (B)(6) HOSPITAL IDENTIFIED THE ORDER OF SELECTION FOR MANUAL DIFFERENTIAL WAS DONE INCORRECTLY. THE MEDICAL TECHNOLOGIST RESULTED THE DIFFERENTIAL BASED OFF A TEST RUN THAT DIDN'T HAVE A WHITE CELL COUNT CONNECTED TO THE ORDER, WHICH IS USED TO CALCULATE THE ABSOLUTE VALUES. THIS WAS NOT A MALFUNCTION OF INSTRUMENT MANAGER. DATA INNOVATIONS WAS UNABLE TO CONFIRM WITH THE USER FACILITY THAT THERE WAS NO PATIENT IMPACT DUE TO THIS USER ERROR AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED ON 23 JULY 2024 THAT AFTER A MANUAL DIFFERENTIAL WAS PERFORMED, THE ABSOLUTE COUNT GENERATED "0.0" AS THE RESULT FOR ALL ABSOLUTE CELL TYPES. RESULTS WERE RELEASED TO THE PATIENT'S CHART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    941171 INSTRUMENT MANAGER SOFTWARE INSTRUMENT MANAGER SOFTWARE JQP DATA INNOVATIONS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown