BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESTEP

    MDR report key: 223872 · Received May 13, 1999

    Report

    Report Number
    2939301-1999-00315
    Event Type
    Malfunction
    Date Received
    May 13, 1999
    Report Date
    April 19, 1999
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CGA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE RPTR DID BACK TO BACK BLOOD GLUCOSE TESTS, WITHIN 10 MINUTES, USING SEPARATE FINGERSTICKS, AND GOT RESULTS OF 131, 169, AND 166 MG/DL. NO SYMPTOMS WERE REPORTED. NO CONTROL SOLUTION AVAILABLE FOR TESTING.

    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 77 YR Other