BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESTEP

    MDR report key: 217974 · Received April 6, 1999

    Report

    Report Number
    2939301-1998-00574
    Event Type
    Malfunction
    Date Received
    April 6, 1999
    Report Date
    October 1, 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

    REPORTER CALLED AND SAYS HE HAS HAD A LOT OF THE "ERL" MESSAGES OVER THE LAST YEAR. REPORTER SIMPLY RETESTED.

    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 62 YR Other