BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTRUMENT MANAGER SOFTWARE

    MDR report key: 24318206 · Received February 11, 2026

    Report

    Report Number
    1225673-2026-00002
    Event Type
    Malfunction
    Date Received
    February 11, 2026
    Date of Event
    January 12, 2026
    Report Date
    February 19, 2026
    Manufacturer
    DATA INNOVATIONS LLC
    Product Code
    MMH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UPON INVESTIGATION WITH THE FACILITY, IT WAS DETERMINED THAT RULES (USER PROGRAMMED LOGIC) WERE NOT FUNCTIONING AS INTENDED DUE TO THE PROGRAMMING OF THOSE RULES. FOR EXAMPLE, THE RULES USED 'AGE IN YEARS' VALUE AND WHEN THIS IS USED, INSTRUMENT MANAGER ONLY RECOGNIZES WHOLE NUMBERS. DATA INNOVATIONS LLC IDENTIFIED THE USER FACILITY SHOULD BE USING THE 'AGE IN DAYS' ALONG WITH DATE AND TIME USER FIELDS TO APPROPRIATELY OBTAIN THE DESIRED ROUNDING. ONCE THE RESULT OF THE ERROR WAS LOCATED, DATA INNOVATIONS ASSISTED THE USER FACILITY IN CORRECTING THE RULE TO CALCULATE THE AGE. WHILE THIS IS NOT A MALFUNCTION OF THE INSTRUMENT MANAGER MEDICAL DEVICE IT IS BEING REPORTED DUE TO THE FACILITIES INABILITY TO PROVIDE A STATEMENT OF PATIENT IMPACT DUE TO THE USER PROGRAMMED LOGIC ERROR.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: DATA INNOVATIONS HAS RECEIVED CONFIRMATION FROM THE USER FACILITY THAT NO PATIENT HARM HAS OCCURRED DUE TO THIS USER PROGRAMMED LOGIC ERROR. INFORMATION FROM ORIGINAL REPORT: UPON INVESTIGATION WITH THE FACILITY, IT WAS DETERMINED THAT RULES (USER PROGRAMMED LOGIC) WERE NOT FUNCTIONING AS INTENDED DUE TO THE PROGRAMMING OF THOSE RULES. FOR EXAMPLE, THE RULES USED 'AGE IN YEARS' VALUE AND WHEN THIS IS USED, INSTRUMENT MANAGER ONLY RECOGNIZES WHOLE NUMBERS. DATA INNOVATIONS LLC IDENTIFIED THE USER FACILITY SHOULD BE USING THE 'AGE IN DAYS' ALONG WITH DATE AND TIME USER FIELDS TO APPROPRIATELY OBTAIN THE DESIRED ROUNDING. ONCE THE RESULT OF THE ERROR WAS LOCATED, DATA INNOVATIONS ASSISTED THE USER FACILITY IN CORRECTING THE RULE TO CALCULATE THE AGE. WHILE THIS IS NOT A MALFUNCTION OF THE INSTRUMENT MANAGER MEDICAL DEVICE IT IS BEING REPORTED DUE TO THE FACILITIES INABILITY TO PROVIDE A STATEMENT OF PATIENT IMPACT DUE TO THE USER PROGRAMMED LOGIC ERROR.

    Description of Event or Problem · 0

    ON (B)(6) 2026, DATA INNOVATIONS WAS MADE AWARE BY A USER FACILITY THAT THE RULE THEY ARE USING TO CALCULATE PATIENT AGE DOES NOT LEAD TO THE CORRECT RESULT. THE CUSTOMER EXPECTED THE RULE TO NOT ROUND TO THE NEAREST WHOLE NUMBER.

    Description of Event or Problem · 0

    ON 12 JAN 2026, DATA INNOVATIONS WAS MADE AWARE BY A USER FACILITY THAT THE RULE THEY ARE USING TO CALCULATE PATIENT AGE DOES NOT LEAD TO THE CORRECT RESULT. THE CUSTOMER EXPECTED THE RULE TO NOT ROUND TO THE NEAREST WHOLE NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238841 INSTRUMENT MANAGER SOFTWARE BLOOD ESTABLISHMENT COMPUTER SOFTWARE AND ACCESSORIES MMH DATA INNOVATIONS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown