BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH II

    MDR report key: 361476 · Received November 8, 2001

    Report

    Report Number
    2939301-2001-00710
    Event Type
    Malfunction
    Date Received
    November 8, 2001
    Report Date
    October 8, 2001
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    CUSTOMER TESTED THE CUSTOMER'S BG AND OBTAINED A READING OF 40 (HAD NO SYMPTOMS) THEN DRANK SOME OJ. A COUPLE OF MINUTES LATER RETESTED ON THE SAME METER AND OBTAINED A 140. CUSTOMER THINKS INCIDENT HAPPENED IN THE AFTERNOON. THE CUSTOMER'S FAMILY MEMBER THEN CALLED LFS TO FIND OUT WHY THERE WAS A BIG DIFFERENCE BETWEEN THE 2 READINGS, CUSTOMER IS ON A SET AMOUNT OF INSULIN 70/30. THERE IS A 89% DIFFERENCE BETWEEN THE 2 READINGS. NOTE: CUSTOMER HAD BEEN STORING STRIPS OUT OF VIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49992 ONE TOUCH II BLOOD GLUCOSE MONITORING KIT/SYSTEM CFR LIFESCAN, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other