BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHANGE HEALTHCARE STRATUS IMAGING PACS

    MDR report key: 18193816 · Received November 22, 2023

    Report

    Report Number
    8022257-2023-00001
    Event Type
    Malfunction
    Date Received
    November 22, 2023
    Date of Event
    October 31, 2023
    Report Date
    November 22, 2023
    Manufacturer
    CHANGE HEALTHCARE CANADA COMPANY
    Product Code
    LLZ
    UDI-DI
    17540262160093
    PMA / PMN Number
    K203249
    Removal / Correction Number
    8022257-11-01-2023-00002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CHANGE HEALTHCARE (CHC) HAS IDENTIFIED AN ISSUE WHERE, UNDER CERTAIN CIRCUMSTANCES, INFORMATION FROM HL7 MESSAGES RECEIVED BY THE STRATUS IMAGING PACS/ IMAGING SHARE SYSTEM HAVE BEEN INCORRECTLY ASSOCIATED WITH ANOTHER PATIENT'S STUDY. NO PATIENT HARM WAS REPORTED AS A RESULT OF THIS ISSUE. THE ROOT CAUSE OF THE ISSUE WAS A DESIGN DEFICIENCY RESULTING FROM CODE INTRODUCED WHICH HANDLES LINKING BETWEEN STUDIES AND REPORTS FOR A SUBSET OF NEW PROCEDURES AND/OR REPORTS. CHANGE HEALTHCARE INITIATED A CLASS II RECALL AN-05008 (RES# (B)(4)) ON NOVEMBER 1, 2023, IN ORDER TO ADDRESS THIS ISSUE. THIS RECALL WAS SUBMITTED TO THE FDA NOVEMBER 10, 2023. CHANGE HEALTHCARE HAS APPLIED A SOFTWARE PATCH TO THE IMPACTED MEDICAL DEVICE TO REMEDIATE THIS ISSUE ON NOVEMBER 1, 2023. CHANGE HEALTHCARE IS WORKING DIRECTLY WITH OUR CUSTOMERS TO IDENTIFY AND ADDRESS THE IMPACTED PATIENT DATA.

    Description of Event or Problem · 0

    UNDER CERTAIN CIRCUMSTANCES, INFORMATION FROM HL7 MESSAGES RECEIVED BY THE STRATUS PACS/ IMAGING SHARE SYSTEM HAVE BEEN INCORRECTLY ASSOCIATED WITH ANOTHER PATIENT'S STUDY WHICH MAY RESULT IN THE FOLLOWING POTENTIAL SCENARIOS: 1. A SUBSET OF PATIENT STUDY METADATA (PATIENT NAME, MRN, ACCESSION NUMBER, DOB, GENDER, STUDY PROCEDURE) HAS BEEN UPDATED WITH ANOTHER PATIENT'S METADATA (PATIENT NAME, MRN, ACCESSION NUMBER, DOB, GENDER, STUDY PROCEDURE). THIS MAY RESULT IN PATIENT'S IMAGES BEING LABELED INCORRECTLY WITH ANOTHER PATIENT'S METADATA AND ASSOCIATED WITH THE WRONG PATIENT RECORD. 2. AS A RESULT OF INCORRECT IMAGE DEMOGRAPHICS, THE MISLABELED IMAGES MAY NOT BE ASSOCIATED WITH THE RECORD FOR THE PATIENT THAT HAD AN IMAGING STUDY. 3. AN ISSUED REPORT ON A STUDY THAT IS SENT TO THE STRATUS IMAGING SYSTEM VIA HL7, MAY GET ATTACHED TO ANOTHER PATIENT'S STUDY. THIS MAY RESULT IN A REPORT BEING ASSOCIATED WITH THE INCORRECT PATIENT STUDY. 4. AS A RESULT OF INCORRECT REPORT ASSOCIATION DESCRIBED ABOVE, SOME PATIENTS WILL HAVE MISSING REPORTS WITH NO REPORT BEING DISPLAYED IN THE STUDY. THE INCORRECT ASSOCIATION OF IMAGE AND REPORT METADATA ACROSS IMAGING STUDIES CAN OCCUR WITHIN YOUR FACILITY OR WITH PATIENT RECORDS FROM ANOTHER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1944076 CHANGE HEALTHCARE STRATUS IMAGING PACS CHANGE HEALTHCARE STRATUS IMAGING PACS LLZ CHANGE HEALTHCARE CANADA COMPANY 1.4 N/A 17540262160093

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown