BEUDAMED
    FDA Adverse Event Other Summary report: N

    INTELEPACS

    MDR report key: 2464138 · Received February 17, 2012

    Report

    Report Number
    9615916-2012-00001
    Event Type
    Other
    Date Received
    February 17, 2012
    Report Date
    February 16, 2012
    Manufacturer
    INTELERAD MEDICAL SYSTEMS
    Product Code
    LLZ
    PMA / PMN Number
    K083520
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS: THE CLIENT'S DEVICE WAS EVALUATED BY EXAMINATION OF EVENT LOGS. THE EVENTS WERE DISCUSSED WITH THE CLIENT. PROBLEM WAS IDENTIFIED AS INCORRECT USAGE OF EXISTING FUNCTIONALITY DUE TO INSUFFICIENT DOCUMENTATION. CLIENT HAS BEEN OFFERED ASSISTANCE IN SETTING UP THE DEVICE CORRECTLY. CONCLUSION: NO CORRECTION TO THE SOFTWARE IS NECESSARY. HOWEVER WE INTEND TO BETTER DOCUMENT CORRECT USAGE OF OUR DEVICE.

    Description of Event or Problem · 1

    WE HAVE BEEN MADE AWARE OF A PROBLEM WITH OUR SOFTWARE BY A CLIENT IN (B)(6). AFTER EVAL, WE CONCLUDED THAT IT SHOULD BE REPORTED AS A "NEAR INCIDENT," AS WE HAVE NO INDICATION THAT ANY PT HARM OCCURRED. THE CAUSE OF THE PROBLEM IS MISUSE OF IMAGE COMMUNICATION PROTOCOLS, AND LACK OF SUFFICIENT NOTIFICATION IN OUR USER DOCUMENTATION AND TRAINING. IN A CONTEXT WHERE TWO OR MORE DIFFERENT HOSPITALS ARE SENDING IMAGES TO OUR DEVICE (INTELEPACS), IT IS POSSIBLE THAT IMAGES FROM TWO DIFFERENT PTS, ONE FROM EACH OF THE TWO HOSPITALS, COULD BE LABELED WITH THE SAME PT IDENTIFIER OR MEDICAL RECORD NUMBER (MRN), AND THEN SENT TO OUR DEVICE. THIS COULD LEAD TO CASES IN OUR DEVICE WHERE A PT'S IMAGES SHOW UP AS PRIOR IMAGES FOR ANOTHER PT. ALL OF THE IMAGES WOULD BE LABELED CORRECTLY, BUT THE USER MAY CHOOSE TO TURN OFF THE LABELS, AND/OR NOT NOTICE THAT THE LABELS IDENTIFY DIFFERENT PTS. IN A SECOND CONTEXT, IF THE IMAGES ASSOCIATED WITH THE DOUBLY USED MRN REFERENCED ABOVE UNDERGO A SUBSEQUENT USER INITIATED CORRECTION OF PT DEMOGRAPHIC INFO, THE PT-IDENTIFYING LABELS ON ALL IMAGES WOULD BE CHANGED, THUS PREVENTING THE USERS FROM KNOWING THE IMAGES MAY BELONG TO ANOTHER PT. WE CONSIDER BOTH CONTEXTS UNLIKELY TO CAUSE CONFUSION, OR MISDIAGNOSIS, SINCE THE PT ANATOMIES ARE READILY RECOGNIZABLE AS BEING DIFFERENT. BOTH OF THE ABOVE CONTEXTS COULD BE AVOIDED BY PROPER USAGE OF OUR DEVICE, USING ITS AVAILABLE FUNCTIONALITY. THAT USAGE IS TO MODIFY THE INCOMING MRNS TO APPEND A CODE FOR THE IMAGE SENDING SITE, THEREBY RESTORING THE UNIQUENESS OF THE IDENTIFIERS. THE ERROR MAY OCCUR BECAUSE OF INSUFFICIENT WARNING IN OUR USER DOCUMENTATION OF THE POTENTIAL IMPACTS OF ADDING NEW IMAGE SENDING LOCATIONS TO OUR DEVICE, AND BECAUSE A CUSTOMER CAN READILY ADD NEW IMAGE SENDING LOCATIONS TO OUR DEVICE WITHOUT TURNING ON THE ABOVE PROVISION. OUR PROPOSED ACTION IS TO NOTIFY THE USER BASE OF THE POTENTIAL PROBLEM AND UPDATE OUR DOCUMENTATION. NO SOFTWARE CHANGE IS REQUIRED, SINCE THE SOLUTION ALREADY EXISTS, BUT IN THIS CASE, WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTELEPACS LLZ INTELERAD MEDICAL SYSTEMS VERSON 4.2.1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1