BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEALTHMYNE QIDS

    MDR report key: 7264643 · Received February 12, 2018

    Report

    Report Number
    3012191385-2017-00001
    Event Type
    Malfunction
    Date Received
    February 12, 2018
    Date of Event
    December 8, 2017
    Report Date
    December 8, 2017
    Manufacturer
    HEALTHMYNE, INC.
    Product Code
    LLZ
    UDI-DI
    B198HM0030
    PMA / PMN Number
    K153289
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HL7 STANDARD AND IHE TESTING FOR THE STANDARD COMBINE TO STATE THAT THE PID FIELDS WHICH CONTAIN PATIENT IDENTIFIERS ARE EXPECTED TO CONTAIN UNIQUE IDENTIFYING INFORMATION IN THE FIRST 15 DIGITS OF THE FIELD, A CARAT SEPARATOR, THEN 4 DIGITS FOR AN ASSIGNING AUTHORITY (TYPICALLY A FACILITY ID), FOR A TOTAL OF 20 DIGITS PER PID (THERE ARE THREE: PID 2, PID 3, PID 4). IN KEEPING WITH THE HL7 STANDARD AND IHE GUIDELINES/TESTING PARAMETERS, HEALTHMYNE IDENTIFIES PATIENTS BASED ON THE FIRST 15 DIGITS OF THE PID FIELDS. IF A FACILITY USES ALL 20 DIGITS AS THE UNIQUE IDENTIFYING INFORMATION AND THE DIGITS THAT UNIQUELY IDENTIFY THE PATIENT ARE WITHIN THE LAST FIVE DIGITS, MULTIPLE PATIENTS COULD BE MERGED TOGETHER AS ONE PATIENT IN HEALTHMYNE. THIS IS ONLY A PROBLEM IF HEALTHMYNE IS RECEIVING MALFORMED HL7 PIDS PER THE IHE GUIDELINES/TESTING PARAMETERS. HEALTHMYNE PARSES THE FIELD WITHOUT CHECKING IT FOR CONFORMANCE. FUTURE RELEASES WILL BE ENHANCED TO CHECK FOR MALFORMED/NON-CONFORMING PATIENT ID FIELDS TO FLAG AND CONTAIN THEM TO PREVENT THEIR USE UNTIL THE MALFORMATION OR NON-CONFORMANCE IS ADDRESSED BY THE FACILITY. ALL CUSTOMERS HAVE BEEN CONTACTED AND CHECKED. THIS OCCURRED AT ONLY ONE CUSTOMER WITH A SUBSET OF STUDIES, & NONE OF THE STUDIES WERE ACCESSED FOR INTERPRETATION.

    Description of Event or Problem · 1

    MALFORMED HL7 PATIENT IDS WERE SENT TO THIS MEDICAL DEVICE RESULTING IN DIFFERENT PATIENT'S STUDIES BEING IDENTIFIED AS THE SAME PATIENT. NONE OF THESE STUDIES WERE READ OR USED FOR DIAGNOSIS. THE ISSUE WAS DISCOVERED DURING A ROUTINE SERVICE CHECK, CUSTOMER WAS CONTACTED, AND THE ISSUE WAS CONTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106023 HEALTHMYNE QIDS HEALTHMYNE QIDS LLZ HEALTHMYNE, INC. 3.0 B198HM0030

    Patients

    Seq Age Sex Outcome Treatment
    1