BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH PROFILE

    MDR report key: 368123 · Received December 19, 2001

    Report

    Report Number
    2939301-2001-01576
    Event Type
    Injury
    Date Received
    December 19, 2001
    Report Date
    November 26, 2001
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CONSUMER REPORTED THAT A PATIENT EXPERIENCED DKA DUE TO INACCURATE ERRATIC READINGS WITH A ONE TOUCH PROFILE METER. PATIENT HAS REPORTEDLY A CYCLICAL HORMONAL PROBLEM ONCE A MONTH THAT COULD CAUSE DKA. DURING THE PROBLEM, PATIENT'S BLOOD GLUCOSE NEEDS TO BE MONITORED EVERY 2 HOURS, AND INSULIN IS GIVEN ACCORDINGLY TO PREVENT DKA. BECAUSE OF THE OT METER INACCURACY, PATIENT HAD DKA WITH VOMITING, SWEATING AND FRUITY BREATH. PATIENT WAS HOSPITALIZED FOR 4 DAYS FOR DKA. PATIENT'S BLOOD GLUCOSE WAS 95MG/DL ON OT METER COMPARED TO A LAB RESULT OF 619MG/DL DONE 10-20 MINUTES APART AT THE TIME OF THE EVENT. NO FURTHER INFORMATION HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57478 ONE TOUCH PROFILE BLOOD GLUCOSE MONITORING KIT/SYSTEM CFR LIFESCAN, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Hospitalization