BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH BASIC ENHANCED

    MDR report key: 510566 · Received February 3, 2004

    Report

    Report Number
    2939301-2004-00745
    Event Type
    Injury
    Date Received
    February 3, 2004
    Date of Event
    January 30, 2004
    Report Date
    January 31, 2004
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PATIENT'S ONE TOUCH BASIC ENHANCED METER WAS REPORTED TO BE READING INACCURATELY LOW AND PATIENT WAS TAKEN TO THE HOSP DUE TO HIGH BLOOD GLUCOSE LEVELS. MEDICAL AFFAIRS SPECIALIST CALLED IN 02/20004 AND SPOKE WITH THE PATIENT'S FAMILY MEMBER WHO PROVIDED ADDITIONAL INFO. FAMILY MEMBER STATED THAT THE PATIENT WAS USING EXPIRED STRIPS THAT HAD BEEN OPENED FOR MORE THAN A YEAR. PATIENT HAD RECEIVED A READING OF 97 MG/DL AND WAS FEELING WEAK WAS VOMITING, AND HAD A PALE FACE. PATIENT WAS DRIVEN TO THE E.R. GREATER THAN 30 MINUTES LATER (EXACT TIME IS UNKNOWN) AND THEIR BLOOD GLUCOSE LEVEL THERE WAS OVER 700 MG/DL. PATIENT WAS GIVEN IV INSULIN AND ADMITTED TO THE HOSP. PATIENT HAS NOT BEEN RELEASED YET. PATIENT IS ON ORAL MEDICATIONS. A CONTROL SOLUTION TEST WAS PERFORMED WITH A NEW VIAL OF TEST STRIPS AND IT WAS WITHIN RANGE. TEST STRIPS WERE REPLACED FOR THE PATIENT. THIS CASE IS REPORTED AS AN ADVERESE EVENT SINCE THE PATIENT SUFFERED A SERIOUS INJURY DUE TO USE ERROR OF USING EXPIRED TEST STRIPS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| L