BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2-WAY MAINFRAME INTERFACE SOFTWARE

    MDR report key: 271561 · Received March 29, 2000

    Report

    Report Number
    2919016-2000-00002
    Event Type
    Malfunction
    Date Received
    March 29, 2000
    Date of Event
    February 10, 2000
    Report Date
    March 29, 2000
    Manufacturer
    DADE MICROSCAN, INC.
    Product Code
    LRG
    Removal / Correction Number
    Z-0405/0406-0
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING IMPLEMENTATION OF VOLUNTARY RECALL #2-0405/0406-0, CUSTOMER UTILIZING THE MICROSCAN PEDIATRIC THERAPY GUIDE SOFTWARE PROGRAM WITH THE MICROSCAN 2-WAY MAINFRAME INTERFACE SOFTWARE REPORTED THEY HAD THE CONFIGURATION WHICH IS AFFECTED BY THE ISSUE WITH PEDIATRIC FLAGGING. BECAUSE THEIR LABORATORY INFORMATION SYSTEM (LIS) DOES NOT SEND THE PEDIATRIC FLAG, PATIENTS IN THE DATA MANAGEMENT SYSTEM (DMS). WHILE THE MIC'S (QUALITATIVE 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 PATIENTS. THE CUSTOMER WAS PROVIDED INSTRUCTIONS FOR CORRECTING THE PROBLEM UNTIL THE SOFTWARE CORRECTION IS AVAILABLE.

    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