BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTRUMENT MANAGER SOFTWARE

    MDR report key: 23648790 · Received November 25, 2025

    Report

    Report Number
    1225673-2025-00007
    Event Type
    Malfunction
    Date Received
    November 25, 2025
    Date of Event
    October 29, 2025
    Report Date
    March 4, 2026
    Manufacturer
    DATA INNOVATIONS LLC
    Product Code
    JQP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: DATA INNOVATIONS IS PROVIDING AN UPDATE TO CORRECT THE PREVIOUSLY ENTERED PRODUCT CODE. THE ORIGINALLY SUBMITTED CODE, JQO, HAS BEEN CORRECTED TO JQP. INFORMATION FROM ORIGINAL REPORT: A USER FACILITY REPORTED TO DATA INNOVATIONS THAT A TEST RESULT COMMENT WAS BEING FILED INCORRECTLY AND REQUESTED ASSISTANCE FROM THE MANUFACTURER. HOWEVER, THE USER FACILITY DID NOT PROVIDE ADDITIONAL INFORMATION REGARDING THE COMMENT, THE TEST INVOLVED, HOW THE COMMENT WAS INCORRECTLY FILED, OR HOW IT SHOULD HAVE BEEN FILED. DESPITE MULTIPLE ATTEMPTS TO OBTAIN FURTHER DETAILS, DATA INNOVATIONS HAS BEEN UNABLE TO TROUBLESHOOT OR ASSIST IN RESOLVING THE COMPLAINT. THIS REPORT IS BEING SUBMITTED BECAUSE AS THE MANUFACTURER, DATA INNOVATIONS IS UNABLE TO RULE OUT MALFUNCTION OR PATIENT HARM.

    Additional Manufacturer Narrative · 0

    A USER FACILITY REPORTED TO DATA INNOVATIONS THAT A TEST RESULT COMMENT WAS BEING FILED INCORRECTLY AND REQUESTED ASSISTANCE FROM THE MANUFACTURER. HOWEVER, THE USER FACILITY DID NOT PROVIDE ADDITIONAL INFORMATION REGARDING THE COMMENT, THE TEST INVOLVED, HOW THE COMMENT WAS INCORRECTLY FILED, OR HOW IT SHOULD HAVE BEEN FILED. DESPITE MULTIPLE ATTEMPTS TO OBTAIN FURTHER DETAILS, DATA INNOVATIONS HAS BEEN UNABLE TO TROUBLESHOOT OR ASSIST IN RESOLVING THE COMPLAINT. THIS REPORT IS BEING SUBMITTED BECAUSE AS THE MANUFACTURER, DATA INNOVATIONS IS UNABLE TO RULE OUT MALFUNCTION OR PATIENT HARM.

    Description of Event or Problem · 0

    A USER FACILITY REPORTED TO DATA INNOVATIONS ON 29 OCT 2025 THAT A TEST RESULT COMMENT WAS FILING INCORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410525 INSTRUMENT MANAGER SOFTWARE CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE JQP DATA INNOVATIONS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1