BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRASMART METER

    MDR report key: 1023249 · Received March 31, 2008

    Report

    Report Number
    2939301-2008-00422
    Event Type
    Injury
    Date Received
    March 31, 2008
    Date of Event
    February 17, 2008
    Report Date
    March 3, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND STRIPS FOR EVALUATION, BUT HAS NOT YET RECEIVED THEM. IF EITHER THE METER OR STRIPS ARE RETURNED, LIFESCAN WILL EVALUATE IT/THEM AND, IF EITHER THE METER OR STRIPS DO NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON MARCH 3, 2008, THE LAY PATIENT'S HUSBAND CONTACTED LIFESCAN (LFS) ALLEGING THAT THE PATIENT'S ONE TOUCH ULTRA SMART METER READ INACCURATELY HIGH. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE HUSBAND SAID, THE ISSUE FIRST OCCURRED IN 2008 AT 3:30 PM. THE PATIENT OBTAINED READINGS OF 359, 241, AND 246 MG/DL ON THE REPORTED PRODUCT WITHIN 10 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <=20% AND/OR <= 20 MG/DL. THE HUSBAND CLAIMED, HIS WIFE TOOK TOO MUCH INSULIN DUE TO THE INACCURATE HIGH READINGS ON THE REPORTED PRODUCT AND BECAME SHAKY AND DIZZY AFTERWARD. SPECIFIC INFORMATION REGARDING THE PATIENT'S DIABETES TREATMENT REGIMEN WAS NOT PROVIDED. THE PATIENT TREATED HERSELF BY EATING FOOD AND/OR DRINKING BEVERAGE. THE CCA NOTED, THAT THE PATIENT CLEANED THE PUNCTURE SITE INCORRECTLY, WHICH CAN CONTRIBUTE TO INACCURATE READINGS. THE PATIENT'S PRODUCTS WERE REPLACED. THIS COMPLAINT IS REPORTED BECAUSE, THE HUSBAND ALLEGES, THAT THE PATIENT BECAME SHAKY AND DIZZY, SYMPTOMS THAT CAN BE ASSOCIATED WITH SEVERE HYPOGLYCEMIA, AFTER TAKING INCREASED INSULIN BASED ON READINGS ON THE LFS PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRASMART METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2743739

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Life Threatening