BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PASCO MICRO-ORGANISM SUSCEPTIBILITY SYSTEM

    MDR report key: 21385 · Received April 21, 1995

    Report

    Report Number
    MW1005699
    Event Type
    Malfunction
    Date Received
    April 21, 1995
    Date of Event
    February 2, 1995
    Report Date
    February 2, 1995
    Manufacturer
    DIFCO
    Product Code
    LKA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    THE INTERPRETATIONS WHICH APPEAR ON THE ATTACHED LIS REPORT, THEREFORE ARE NOT PROVIDED BY THE PASCO SOFTWARE. CONCLUSION IS THAT THE ERRONEOUS INTERPRETATIONS WERE LOADED INTO CO'S SYSTEM BY THE MICROBIOLOGY LAB PERSONNEL OF ST. JOSEPH HOSP. CO RECOMMENDED THAT ALL RESULTS AND ASSOCIATED INTERPRETATIONS AND MESSAGES BE CAREFULLY REVIEWED BEFORE CHANGES ARE MADE OR REPORTS ARE RELEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PASCO MICRO-ORGANISM SUSCEPTIBILITY SYSTEM SOFTWARE LKA DIFCO

    Patients

    Seq Age Sex Outcome Treatment
    1 *