BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESTEP

    MDR report key: 191292 · Received October 9, 1998

    Report

    Report Number
    2939301-1998-00267
    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
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER REC'D SEVERAL ER1 MESSAGE AND RETESTED EACH TIME, REC'D A RESULT BUT CANNOT RECALL THE ACTUAL VALUE. METER MEMORY RESULTS: 159, 155, 141, 153, 158, 145, 146, 138, 146, 148.

    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 41 YR Other