BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESTEP

    MDR report key: 191264 · Received October 9, 1998

    Report

    Report Number
    2939301-1998-00255
    Event Type
    Malfunction
    Date Received
    October 9, 1998
    Report Date
    September 10, 1998
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CGA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    DURING CONTACT WITH LIFESCAN THE REPORTER PERFORMED A CONTROL TEST AND REC'D AN ER1 MESSAGE. SHE HAD NEVER SEEN THE ER1 MESSAGE BEFORE. SHE COMPARED THE CONTROL TEST STRIP CONFIRMATION DOT TO THE VIAL COLOR CHART AND IT WAS VERY DARK BLUE. REVIEW OF THE METER MEMORY PROVIDED BY REPORTER ER1: 151, 121, 120, 130, 154, 184, 121, 127, 128.

    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 48 YR Other