BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA

    MDR report key: 431223 · Received December 4, 2002

    Report

    Report Number
    2939301-2002-11543
    Event Type
    Injury
    Date Received
    December 4, 2002
    Date of Event
    November 28, 2002
    Report Date
    December 1, 2002
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER'S OT ULTRA METER WAS READING INACCURATELY HIGH. THEY WERE FEELING DIZZY SO THEY BEGAN TO TEST THEIR BLOOD. THEY DID A SERIES OF BACK TO BACK READINGS: 116, 103, 105, 99, 98 AND 95 MG/DL. THEY WERE STILL NOT FEELING WELL SO FAMILY MEMBER CALLED THE PARAMEDICS. THEY ARRIVED WITHIN 30 MINUTES AND TESTED THEIR BLOOD SUGAR ON THE PARAMEDICS' METER, THE RESULT WAS 48 MG/DL. THE PARAMEDICS TOOK THEM TO THE HOSP WHERE THEY WERE GIVEN A GLUCOSE IV. THEY WERE RELEASED FROM THE HOSP THE SAME DAY AFTER THEIR BLOOD SUGAR WAS STABLIZED. THERE WERE NO QUALITY CONTROL TESTS PERFORMED ON THE METER. THE METER HAS BEEN REPLACED FOR THE CUSTOMER'S COMFORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| L