BEUDAMED
    FDA Adverse Event Summary report: N

    GLUCOMETER ELITE TEST STRIP

    MDR report key: 19474 · Received December 9, 1994

    Report

    Report Number
    MW4000625
    Date Received
    December 9, 1994
    Report Date
    December 9, 1994
    Manufacturer
    AMES DIAGNOSTIC DIV. MILES, INC.
    Product Code
    CFR
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    PT WROTE FOR A PARTICULAR BRAND OF TEST STRIPS. RPTR FILLED WITH ANOTHER BRAND. PT IS 25 YEAR MALE. PT DISCOVERED ERROR ON 11/16/94. STRIPS DISPENSED ON 10/4/94.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLUCOMETER ELITE TEST STRIP TEST STRIP CFR AMES DIAGNOSTIC DIV. MILES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR