BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESTEP

    MDR report key: 192093 · Received October 13, 1998

    Report

    Report Number
    2939301-1998-00321
    Event Type
    Malfunction
    Date Received
    October 13, 1998
    Report Date
    September 14, 1998
    Manufacturer
    LIFESCAN INC.
    Product Code
    CGA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE REPORTER RECEIVED AN ER1 MESSAGE IN 11/1996 WITH HER FIRST ATTEMPT TO USE THE METER AND DID NOT USE THE METER FOR BLOOD TESTING BECAUSE SHE COULD NOT MOVE PAST THE ER1 MESSAGE.

    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 73 YR Other