BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORIGIN DATA MANAGEMENT (VERSION 3.2, SOFTWARE COMPONENT)

    MDR report key: 21949668 · Received May 2, 2025

    Report

    Report Number
    8043933-2025-00033
    Event Type
    Malfunction
    Date Received
    May 2, 2025
    Date of Event
    March 10, 2025
    Report Date
    May 2, 2025
    Manufacturer
    BRAINLAB AG
    Product Code
    QIH
    PMA / PMN Number
    K243698
    Removal / Correction Number
    96241
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO THIS ISSUE, FOR EXAMPLE, DATA FROM PATIENT_A MAY BE AUTOMATICALLY AND INCORRECTLY MERGED INTO AN UNRELATED PATIENT_B BY THE ODM SOFTWARE, WHICH LEADS TO: · THE UNINTENDED DISPLAY OF DATA FROM PATIENT_A IN PATIENT_B. (BRAINLAB DATA SELECTION APPLICATION). · THE UNINTENDED REMOVAL OF PATIENT_A FROM THE PATIENT LIST. (BRAINLAB PATIENT SELECTION APPLICATION). IF THE AUTOMATIC ERRONEOUS MERGING OF DATA FROM TWO UNRELATED PATIENT RECORDS IS NOT DETECTED BY THE USER IN THE SUBSEQUENT STEPS OF TREATMENT PREPARATION, AND DATA FROM PATIENT_A IS USED TO MAKE CLINICAL DECISIONS FOR PATIENT_B, THIS COULD, IN A WORST-CASE SCENARIO RESULT IN TREATMENT ERROR OR SERIOUS INJURY. AT THE TIME OF WRITING, THERE HAS BEEN NO REPORTED NEGATIVE CLINICAL EFFECT ON ANY PATIENT DUE TO THIS ISSUE. ACCORDING TO THE RESULTS OF THE BRAINLAB INVESTIGATION AND THE INFORMATION PROVIDED BY THE HOSPITAL, IT CAN BE CONCLUDED THAT THE EFFECT OBSERVED WAS DUE TO A SYSTEMATIC ERROR FOR WHICH BRAINLAB HAS INITIATED ONGOING FIELD SAFETY CORRECTIVE ACTIONS: 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 ALL APPLICABLE REGULATORY AUTHORITIES. ON FEBRUARY 4TH, 2025, BRAINLAB ISSUED THE 21 CFR 806 REPORT OF CORRECTION TO THE FDA. - BRAINLAB IS IN THE PROCESS OF INFORMING 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 INITIATED DISTRIBUTION OF THE NOTIFICATION LETTERS ON FEBRUARY 7TH, 2025. AN ACTIVE REPLY BY THE CONSIGNEES WAS FOLLOWED, WHERE NECESSARY, VIA FURTHER DIFFERENT COMMUNICATION MEDIA. BRAINLAB ALSO FOLLOWS WITH THE CONSIGNEES TO CONFIRM THAT THE CONTAINED USER CORRECTIVE ACTION IS IMPLEMENTED AT THE HOSPITAL (WILL BE ADHERED TO BY THE USERS) FOR THE AFFECTED ORIGIN DATA MANAGEMENT SOFTWARE VERSIONS (3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1). IF DESPITE SEVERAL ATTEMPTS AN ACTIVE REPLY BY THE CONSIGNEE (HOSPITAL/USER) IS NOT RECEIVED, A SUCCESSFUL DELIVERY OF THE NOTIFICATION LETTER (E.G., VIA COURIER) WILL BE DOCUMENTED. - BRAINLAB WILL PROVIDE A SOFTWARE REVISION OF ORIGIN DATA MANAGEMENT SOFTWARE WITH THE DESCRIBED ISSUE CORRECTED TO ALL AFFECTED CUSTOMERS. DEPENDING ON THE REGULATORY CLEARANCE IN CERTAIN MARKETS, BRAINLAB WILL ACTIVELY CONTACT THE AFFECTED CUSTOMERS AS EARLY AS MAY 2025 TO SCHEDULE THE UPDATE. THE UPDATE INSTALLATION FOR ALL AFFECTED CUSTOMERS IS TENTATIVELY PLANNED TO BE COMPLETED (WORLDWIDE) BY THE END OF JUNE 2027.

    Description of Event or Problem · 0

    AN INCORRECT MERGE OF PATIENT RECORDS FROM TWO DIFFERENT PATIENTS WAS DETECTED AT A HOSPITAL. ACCORDING TO THE HOSPITAL, THERE WAS NEITHER HARM NOR NEGATIVE EFFECT TO EITHER OF THE PATIENTS DUE TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189489 ORIGIN DATA MANAGEMENT (VERSION 3.2, SOFTWARE COMPONENT) Automated Radiological Image Processing Software QIH BRAINLAB AG 30074-04C

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown