BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERGE LIS

    MDR report key: 5959169 · Received September 18, 2016

    Report

    Report Number
    2183926-2016-00725
    Event Type
    Malfunction
    Date Received
    September 18, 2016
    Date of Event
    August 18, 2016
    Report Date
    August 18, 2016
    Manufacturer
    MERGE HEALTHCARE
    Product Code
    JQP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INTERNAL INVESTIGATION WAS PERFORMED BASED ON THE CUSTOMER'S ALLEGATION. NO ISSUE WAS IDENTIFIED WITH THE REPORTING OF THE ACTUAL RESULT BUT WITH THE FLAGGING ASSOCIATED WITH A SPECIFIC MEDICATION. SINCE THE CUSTOMER MANUALLY CORRECTED THE FLAG ASSOCIATED WITH THE MEDICATION, MERGE HEALTHCARE WAS NOT ABLE TO THOROUGHLY INVESTIGATE THE CAUSE OF THE FLAGGING ISSUE. MERGE HEALTHCARE DETERMINED THE CUSTOMER WAS WORKING WITH AN OLDER VERSION OF MERGE LIS SOFTWARE. SINCE THE CUSTOMER'S RELEASED VERSION, NEWER VERSIONS OF LIS SOFTWARE HAVE BEEN RELEASED WHICH INCORPORATED CORRECTIONS TO FLAGGING ISSUES IN THE TOXICOLOGY WORKFLOW. THE CUSTOMER WAS UPGRADED TO THE CURRENT VERSION OF MERGE LIS SOFTWARE TO PREVENT FLAGGING ISSUES FROM REOCCURRING.

    Description of Event or Problem · 1

    MERGE LIS IS INTENDED TO BE USED FOR RECEIVING, VIEWING, COMMUNICATING AND STORING RESULTS FROM LABORATORY MODALITIES. LIS FUNCTIONALITY INCLUDES, RECORDING, ANNOTATING, CREATING/PRINTING LABELS, CALCULATIONS, PATIENT MEDICATION/INTERACTION INFORMATION, MONITORING, REPORTING AND TRENDING OF PATIENT LAB RESULTS. ON (B)(6) 2016, A TOXICOLOGY CUSTOMER REPORTED INCORRECT FLAGGING OF CONSISTENT (C) OR INCONSISTENT (I) ON A PATIENT RESULT FOR A MEDICATION ON A PATIENT ACCESSION. THE CUSTOMER RECOGNIZED THE FLAG WAS INCORRECT AND MANUALLY CORRECTED THE FLAG FOR THE MEDICATION. MERGE HEALTHCARE IDENTIFIED THE CUSTOMER WAS WORKING WITH AN OLDER VERSION OF MERGE LIS SOFTWARE. SINCE THE CUSTOMER'S RELEASED VERSION, NEWER VERSIONS OF LIS SOFTWARE HAVE BEEN RELEASED WHICH INCORPORATED CORRECTIONS TO FLAGGING ISSUES IN THE TOXICOLOGY WORKFLOW. INACCURATE LAB RESULTS REPORTED OR ASSOCIATED WITH A PATIENT COULD LEAD TO AN INCORRECT DIAGNOSTIC EVALUATION RESULTING IN AN UNNECESSARY PROCEDURE OR INAPPROPRIATE TREATMENT; HOWEVER, THERE IS NO INDICATION THAT THE ISSUE, REPORTED BY THE CUSTOMER, RESULTED IN A DEATH OR SERIOUS INJURY. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610742 MERGE LIS CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE JQP MERGE HEALTHCARE MERGE LIS V 4.1.1

    Patients

    Seq Age Sex Outcome Treatment
    1