BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERGE UNITY PACS

    MDR report key: 6734991 · Received July 23, 2017

    Report

    Report Number
    2183926-2017-00155
    Event Type
    Malfunction
    Date Received
    July 23, 2017
    Date of Event
    June 23, 2017
    Report Date
    June 23, 2017
    Manufacturer
    MERGE HEALTHCARE
    Product Code
    LLZ
    PMA / PMN Number
    K041935
    Removal / Correction Number
    2183926-07/12/2017-010-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON AN INVESTIGATION PERFORMED BY MERGE HEALTHCARE, THE DIRECT CAUSE IS THAT THE PATIENT HISTORY OF ATYPICAL HYPERPLASIA INDICATION WAS BEING SET OR CLEARED BASED ON THE MOST RECENT BIOPSY RESULTS. THIS ISSUE ONLY IMPACTED CUSTOMERS ON UNITY RELEASE 10.0.6 AND 10.0.7 WHO WERE LICENSED FOR MAMMO TRACKING. DURING THE INVESTIGATION, IT WAS DETERMINED THAT THE CHANGE THAT INTRODUCED THE ISSUE WAS NOT INTEGRATED INTO HIGHER RELEASES (11.X AND ABOVE). THEREFORE, CUSTOMERS WITH THESE IMPACTED RELEASES WILL BE UPGRADED TO CORRECT THE ISSUE. THE POTENTIAL IMPACT TO A PATIENT HAS BEEN REVIEWED AND THE RISK LEVEL HAS BEEN ASSESSED AS MEDIUM (NON-SERIOUS INJURY). THERE WAS A VIABLE WORK AROUND FOR THIS ISSUE. USE THE OUTSIDE BIOPSIES SECTION WHEN ATYPICAL HYPERPLASIA IS INVOLVED. DEFECT RESOLVED IN FIX VERSION/S: 11.1.2 PATCH 5, PATCH REQUEST THIS CUSTOMER AND ALL ASSOCIATED SITES WERE UPGRADED ON 6/16/2018 TO R11.1.2.7 BUILD (76.15682) WHICH CONTAINS THE FIX FOR THIS ISSUE. REVISED INFORMATION CONTAINED IN THIS SUPPLEMENTAL REPORT INCLUDES THE FOLLOWING: G7 - INDICATION THAT THIS IS FOLLOW-UP REPORT 001 H1 - INDICATION OF MALFUNCTION AS REPORTABLE EVENT H2 - INDICATION OF ADDITIONAL INFORMATION H6 - EVALUATION CODES: METHODS CODE: 10 - TESTING OF ACTUAL/SUSPECTED DEVICE RESULTS CODE: 104- SOFTWARE PROBLEM IDENTIFIED 110- DESIGN ERROR CONCLUSIONS CODE: 12 - CAUSE TRACED TO DEVICE DESIGN H10 - INDICATION OF ADDITIONAL MANUFACTURER INFORMATION IS CONTAINED IN THIS FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 1

    UPON RESEARCHING THE CUSTOMER'S QUESTION REGARDING THE CALCULATIONS OF RISK, MERGE HEALTHCARE IDENTIFIED AN ISSUE WHERE ATYPICAL HYPERPLASIA MAY NOT BE FACTORED INTO THE BREAST RISK CALCULATION. A MISCALCULATION REGARDING POTENTIAL RISK COULD RESULT IN A PATIENT NOT RECEIVING THE RECOMMENDED TREATMENT AND/OR RECEIVING TREATMENT THAT IS NOT NEEDED. MERGE HEALTHCARE IS CONTINUING TO INVESTIGATE THE ALLEGATION FROM THE CUSTOMER AND IS PLANNING A CORRECTION (2182926-07/21/2017-010-C). .

    Description of Event or Problem · 1

    MERGE UNITY PACS IS A MEDICAL IMAGE AND INFORMATION MANAGEMENT SYSTEM THAT IS USED FOR VIEWING, SELECTION, PROCESSING, PRINTING, TELECOMMUNICATIONS, AND MEDIA INTERCHANGE OF MEDICAL IMAGES FROM A VARIETY OF DIAGNOSTIC IMAGING SYSTEMS. ON (B)(6) 2017, A CUSTOMER CONTACTED MERGE TECHNICAL SUPPORT WITH QUESTIONS ABOUT HOW THE MERGE UNITY BREAST RISK ASSESSMENT CALCULATES THE RISK. THE CUSTOMER REPORTED THAT A PATIENT HAD TWO PREVIOUS NEGATIVE EXAMS THAT AND THE PATIENT'S FAMILY HAS NO HISTORY OF BREAST CANCER. HOWEVER, WHEN PERFORMING THE RISK ASSESSMENT IN MERGE UNITY FOR THIS PARTICULAR PATIENT, THE LIFETIME RISK LEVEL WAS NOT WHAT THE CUSTOMER EXPECTED. THERE WAS NO REPORTED ADVERSE EVENT TO THE PATIENT. A MISCALCULATION REGARDING THE POTENTIAL RISK OF BREAST CANCER COULD RESULT IN A PATIENT NOT RECEIVING THE RECOMMENDED TREATMENT AND/OR RECEIVING TREATMENT THAT IS NOT NEEDED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515360 MERGE UNITY PACS PICTURE AND ARCHIVING COMMUNICATIONS SYSTEM LLZ MERGE HEALTHCARE UNITY PACS R11.1.2.2

    Patients

    Seq Age Sex Outcome Treatment
    1