BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESTEP

    MDR report key: 317566 · Received February 21, 2001

    Report

    Report Number
    2939301-2001-00139
    Event Type
    Malfunction
    Date Received
    February 21, 2001
    Report Date
    January 22, 2001
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PATIENT REPORTED OBTAINING BLOOD SUGAR LEVELS OF 270, 230, 277, 297 AND 300 MG/DL IN A BACK TO BACK TESTING SESSION ON THEIR SS METER. NO SYMPTOMS WERE REPORTED. LFS REP REVIEWED QC PROCEDURES AND DISCUSSED SERIES OF VARIATION (SOV). THE METER WAS REPLACED. NO ALLEGATIONS OF HARM WERE MADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6713 SURESTEP BLOOD GLUCOSE MONITORING KIT/SYSTEM CFR LIFESCAN, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other