BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESTEP

    MDR report key: 201796 · Received December 9, 1998

    Report

    Report Number
    2939301-1998-00996
    Event Type
    Malfunction
    Date Received
    December 9, 1998
    Report Date
    September 9, 1998
    Manufacturer
    LIFESCAN INC.
    Product Code
    CGA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATED THAT SHE HAD GOTTEN ERL MESSAGES, RETESTED, AND RECEIVED READINGS IN HER NORMAL RANGE OF 120 - 140 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURESTEP BLOOD GLUCOSE METER CGA LIFESCAN INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other