BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLUCOFILM

    MDR report key: 11621 · Received February 18, 1994

    Report

    Report Number
    MW1000833
    Event Type
    Malfunction
    Date Received
    February 18, 1994
    Date of Event
    January 25, 1994
    Report Date
    February 2, 1994
    Manufacturer
    MILES, INC.
    Product Code
    CFR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    NURSING UNITS AND LAB REPORTED INACCURACY IN THE TEST STRIPS. 'ERR' MESSAGE WAS APPEARING IN THE MACHINES. NEW LOT # AND PROG # USED ON SAME MACHINE HAS NO PROBLEM (L3360093 9/95 PROG #2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLUCOFILM CFR MILES, INC. E3189083

    Patients

    Seq Age Sex Outcome Treatment
    1 *