BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORIGIN DATA MANAGEMENT (SOFTWARE COMPONENT)

    MDR report key: 21002079 · Received December 23, 2024

    Report

    Report Number
    8043933-2024-00090
    Event Type
    Malfunction
    Date Received
    December 23, 2024
    Date of Event
    November 27, 2024
    Report Date
    February 6, 2025
    Manufacturer
    BRAINLAB AG
    Product Code
    QIH
    PMA / PMN Number
    K234047
    Removal / Correction Number
    96241
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B2, H1: A RISK TO PATIENT HEALTH COULD NOT BE EXCLUDED FOR THESE SPECIFIC CIRCUMSTANCES, BECAUSE IN THE EVENT THAT AN AUTOMATIC INCORRECT MERGE OF UNRELATED PATIENT RECORDS IS NOT DETECTED BY THE USER, IT COULD, IN A WORST-CASE SCENARIO, MISLEAD THE USER, LEADING TO INEFFECTIVE TREATMENT OR SERIOUS INJURY, ALTHOUGH ACCORDING TO THE HOSPITAL: THERE WAS NO NEGATIVE CLINICAL EFFECT ON PATIENT TREATMENT DUE TO THIS ISSUE FOR THE SIX CASES THAT WERE DISCOVERED. H6: THROUGH THE INVESTIGATION OF THIS ISSUE, BRAINLAB HAS DETERMINED TWO SOFTWARE ANOMALIES IN BRAINLAB ORIGIN DATA MANAGEMENT (ODM) SOFTWARE VERSIONS 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1, THAT LEAD TO AUTOMATIC AND INCORRECT MERGES OF PATIENT RECORDS, WITHOUT ANY USER NOTIFICATION, UNDER SPECIFIC CIRCUMSTANCES. CIRCUMSTANCES IN WHICH THE ISSUE OCCURS: THE PROBLEM OCCURS IF SPECIFIC WORKFLOWS ARE APPLIED EITHER IN THE BRAINLAB PATIENT SELECTION APPLICATION, OR IN A HOSPITAL INFORMATION SYSTEM (HIS) THAT IS CONNECTED TO THE ABOVE-LISTED VERSIONS OF BRAINLAB ODM SOFTWARE: 1. IF THE PATIENT ID IS CHANGED VIA MERGE OR EDIT FUNCTION AND SUBSEQUENTLY ONLY THE GENDER OF THAT PATIENT RECORD IS CHANGED, OR, 2. IF THE PATIENT ID OF ONE PATIENT RECORD IS CHANGED FROM ITS ORIGINAL VALUE TO A NEW VALUE AND SUBSEQUENTLY, THIS ORIGINAL VALUE IS APPLIED (VIA MERGE OR EDIT FUNCTION) AS THE TARGET PATIENT ID OF ANOTHER PATIENT RECORD. H7: BRAINLAB IS IN THE PROCESS OF ISSUING FIELD SAFETY CORRECTIVE ACTION (FSCA) INFORMATION FOR THIS POTENTIAL SAFETY ISSUE TO THE FDA AS WELL AS ALL APPLICABLE REGULATORY AUTHORITIES. BRAINLAB SUBMITTED A 21 CFR 806 REPORT TO THE FDA ON FEBRUARY 4TH, 2025 (RES NUMBER: 96241). BRAINLAB WILL INFORM ALL AFFECTED CUSTOMERS OF THE POTENTIAL SAFETY ISSUE WHEN USING THE RELEVANT BRAINLAB ORIGIN DATA MANAGEMENT (ODM) SOFTWARE VERSIONS, THE INTERMEDIATE ACTIONS USERS SHALL APPLY TO AVOID THE ISSUE, AND THE CORRECTIVE ACTIONS THAT BRAINLAB IS TAKING TO CORRECT THIS ISSUE. BRAINLAB PLANS TO INITIATE DISTRIBUTION OF THE NOTIFICATION LETTERS ON FEBRUARY 7TH, 2025.

    Additional Manufacturer Narrative · 0

    B2, H1: A RISK TO THE PATIENT'S HEALTH COULD NOT BE EXCLUDED FOR THESE SPECIFIC CIRCUMSTANCES, BECAUSE IN THE EVENT THAT AN AUTOMATIC INCORRECT MERGE OF PATIENT DATA IS NOT DETECTED BY THE USER, IT COULD, IN A WORST-CASE SCENARIO, MISLEAD THE USER, LEADING TO INEFFECTIVE TREATMENT OR SERIOUS INJURY, ALTHOUGH ACCORDING TO THE HOSPITAL: NO INCORRECTLY MERGED TREATMENT PLAN WAS USED TO TREAT A PATIENT AND THERE WAS NO HARM OR NEGATIVE EFFECT TO ANY PATIENT DUE TO THIS ISSUE. H6, H7: A COMPREHENSIVE INVESTIGATION BY BRAINLAB REGARDING THIS SPECIFIC EVENT IS CURRENTLY ONGOING AND FINAL CONCLUSIONS ARE PENDING. BRAINLAB PLANS TO ISSUE A FOLLOW-UP REPORT TO THE FDA UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    A CUSTOMER AT A HOSPITAL IN AUSTRALIA DISCOVERED THE PATIENT PLAN FOR AN INDIVIDUAL WITH A SPECIFIC ID IN AN UNRELATED PATIENT RECORD, WITH A DIFFERENT ID. AN INVESTIGATION BY BRAINLAB UNCOVERED FIVE MORE RELATED CASES OF AUTOMATIC INCORRECT MERGES OF PATIENT RECORDS AT THE SAME SITE. ACCORDING TO THE HOSPITAL: THERE WAS NO NEGATIVE CLINICAL EFFECT ON PATIENT TREATMENT DUE TO THIS ISSUE FOR THE SIX CASES THAT WERE DISCOVERED.

    Description of Event or Problem · 0

    A USER OF BRAINLAB ELEMENTS 6.0 INFORMED BRAINLAB THAT THE PATIENT PLAN FOR A PATIENT WITH A SPECIFIC ID WAS FOUND IN A DIFFERENT PATIENT (WITH A DIFFERENT ID). AN INVESTIGATION BY BRAINLAB UNCOVERED 5 MORE RELATED CASES OF INCORRECT PATIENT MERGES AT THE SAME SITE. ACCORDING TO THE HOSPITAL: NO INCORRECTLY MERGED TREATMENT PLAN WAS USED TO TREAT A PATIENT AND THERE WAS NO HARM OR NEGATIVE EFFECT TO ANY PATIENT DUE TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76823 ORIGIN DATA MANAGEMENT (SOFTWARE COMPONENT) AUTOMATED RADIOLOGICAL IMAGE PROCESSING SOFTWARE QIH BRAINLAB AG 30074-04B

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other