BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2-WAY MAINFRAME INTERFACE SOFTWARE

    MDR report key: 260623 · Received January 31, 2000

    Report

    Report Number
    2919016-2000-00001
    Event Type
    Malfunction
    Date Received
    January 31, 2000
    Date of Event
    November 3, 1999
    Report Date
    January 31, 2000
    Manufacturer
    DADE MICROSCAN, INC.
    Product Code
    LRG
    Removal / Correction Number
    2919016-X/XX/00-001C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    CUSTOMER UTILIZING THE MICROSCAN PEDIATRIC THERAPY GUIDE SOFTWARE PROGRAM REPORTED THAT PEDIATRIC PT RECORDS SENT BY THE LABORATORY INFO SYSTEM (LIS) UTILIZING THE MICROSCAN 2-WAY MAINFRAME INTERFACE SOFTWARE (MFI) ARE NOT ALWAYS FLAGGED AS PEDIACTRIC IN THE MICROSCAN DATA MANAGEMENT SYSTEM (DMS). WHILE THE "MIC'S" (QUANTITATIVE RESULTS) REPORTED BY THE SYSTEM ARE UNAFFECTED, THIS COULD CAUSE THE CATEGORICAL INTERPRETATIONS (QUALITATIVE RESULTS) AND DOSAGES REPORTED BY THE "DMS" TO BE INCORRECT FOR SOME PEDIATRIC PTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2-WAY MAINFRAME INTERFACE SOFTWARE OPTIONAL SOFTWARE UTILIZED WITH MICROBIOLOGY READER LRG DADE MICROSCAN, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other