BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESTEP

    MDR report key: 217878 · Received April 2, 1999

    Report

    Report Number
    2939301-1999-00187
    Event Type
    Malfunction
    Date Received
    April 2, 1999
    Report Date
    March 3, 1999
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    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 RPTR DID BACK TO BACK BLOOD GLUCOSE TESTS, USING DIFFERENT FINGERSTICKS, WITH RESULTS OF 59 MG/DL AND 125 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURESTEP BLOOD GLUCOSE METER CFR LIFESCAN, INC. 1001 A804798A

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other