BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRASMART METER

    MDR report key: 1082195 · Received July 24, 2008

    Report

    Report Number
    2939301-2008-01491
    Event Type
    Injury
    Date Received
    July 24, 2008
    Date of Event
    July 10, 2008
    Report Date
    July 13, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON JULY 13, 2008, THE LAY-USER/REPORTER CONTACTED LIFESCAN (LFS) ON BEHALF OF THE LAY-USER/PT ALLEGING THAT ONE TOUCH ULTRASMART METER IS GIVING INNACURATE HIGH READINGS. ON THREE DAYS PRIOR, THE PT REPORTED BLOOD GLUCOSE RESULTS OF "309 MG/DL" WITH A LIFESCAN METER AND "239 MG/DL" ON ANOTHER METER, PERFORMED WITHIN 10 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <=30 % AND/OR <=30 MG/DL. AS A RESULT OF THE REPORTED ISSUE, THE PT REPORTEDLY INCREASED HIS HUMALOG INSULIN TO 13 UNITS. AFTER THE REPORTED ISSUE BEGAN, THE PT REPORTEDLY WAS FEELING SHAKY. IT IS NOT CLEAR IF THE PT FELT SHAKY AFTER HE TOOK AN INCREASE DOSE OF INSULIN OR BEFORE. THE REPORTER INDICATED THAT THE PT DID NOT RECEIVE ANY MEDICAL INTERVENTION AS A RESULT OF THE REPORTED ISSUE. IT WOULD HAVE BEEN HELPFUL TO KNOW THE PT'S TESTING FREQUENCY, DIABETES MEDICATION REGIMEN, AND THE EVENTS PRIOR TO THE PT'S ALLEGED REPORTED SYMPTOMS SUCH AS FOOD INTAKE, DIABETES MEDICATION REGIMEN, READING FROM THE SUBJECT METER, AND PHYSICAL ACTIVITY. IN ADDITION, IT WOULD BE HELPFUL WHAT THE TIME AND DATE WHEN THE REPORTED SYMPTOMS BEGAN, HOW THE PT TREATED HIS SYMPTOMS, THE DURATION OF THE SYMPTOMS, AND IF HIS SYMPTOM ABATED. DURING TROUBLESHOOTING, THE CUSTOMER CARE ADVOCATE VERIFIED THAT THE TESTING TECHNIQUE WAS CORRECT, THE PUNCTURE AREA WAS CLEANED APPROPRIATELY, AND THE REPORTED METER READINGS WERE CONFIRMED IN THE METER'S MEMORY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT HAD SYMPTOMS THAT COULD BE SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE REPORTED ISSUE BEGAN. REPLACEMENT PRODUCTS WERE SENT TO THE PT.

    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 36 YR Life Threatening