BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRASMART METER

    MDR report key: 1040603 · Received May 9, 2008

    Report

    Report Number
    2939301-2008-00700
    Event Type
    Injury
    Date Received
    May 9, 2008
    Date of Event
    April 20, 2008
    Report Date
    April 21, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    SERIAL NUMBER AND LOT NUMBER NOT PROVIDED. 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

    IN 2008 THE LAY PATIENT'S DAUGHTER CONTACTED LIFESCAN (LFS) ALLEGING THAT THE PT'S ONE TOUCH ULTRA SMART METER READ INACCURATELY HIGH. ON APRIL 30, 2008 THE MEDICAL AFFAIRS SPECIALIST (MAS) SPOKE WITH THE DAUGHTER TO OBTAIN ADDITIONAL INFORMATION INCLUDED BELOW. THE DAUGHTER SAID THE PATIENT TAKES LANTUS INSULIN EACH MORNING AT 10:00 AM AND ADJUSTS THE DOSAGE BASED ON HER METER READING. THE DAUGHTER DID NOT KNOW THE SPECIFIC DOSE ADJUSTMENT REGIMEN. THE DAY BEFORE THE DAUGHTER CALLED LFS (ONE DAY EARLIER), THE PATIENT OBTAINED A READING OF 193 MG/DL AND ANOTHER, UNKNOWN ELEVATED READING ON THE REPORTED METER. THE PATIENT THEN TOOK LANTUS INSULIN PER HER REGIMEN. THE DAUGHTER SAID SHORTLY AFTERWARD, THE PATIENT PASSED OUT AND EMS WAS CALLED. EMT'S OBTAINED A RESULT OF < 24 MG/DL ON THEIR METER. THE EMT'S STARTED AN IV AND ADMINISTERED IV GLUCOSE. THE PATIENT REGAINED CONSCIOUSNESS AND WAS NOT TAKEN TO THE HOSPITAL. SHE WAS ADVISED TO CONTACT HER PHYSICIAN REGARDING THE INCIDENT. THE DAUGHTER TOLD THE MAS SHE DID NOT KNOW WHEN OR IF A RESULT OF 69 MG/DL (AS PREVIOUSLY NOTED) WAS OBTAINED. THE CUSTOMER CARE ADVOCATE (CCA) NOTED THAT THE PATIENT FOLLOWED CORRECT TESTING TECHNIQUE. THE PATIENT'S PRODUCTS WERE REPLACED. THE COMPLAINT IS REPORTED BECAUSE THE PATIENT'S DAUGHTER ALLEGES THE PATIENT TOOK INSULIN BASED ON INACCURATELY HIGH READINGS ON THE LFS PRODUCT AND SHORTLY THEREAFTER LOST CONSCIOUSNESS. THE DAUGHTER CLAIMS EMT'S OBTAINED A HYPOGLYCEMIC BLOOD GLUCOSE READING AND TREATED THE PATIENT WITH IV GLUCOSE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Life Threatening| R