BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRASMART METER

    MDR report key: 1023302 · Received April 1, 2008

    Report

    Report Number
    2939301-2008-00429
    Event Type
    Injury
    Date Received
    April 1, 2008
    Date of Event
    February 24, 2008
    Report Date
    March 7, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE LAY-USER/PT CONTACTED LIFESCAN (LFS) ALLEGING THAT THE ONE TOUCH ULTRASMART METER IS GIVING INACCURATE HIGH READINGS. ON MARCH 25, 2008, THIS MEDICAL AFFAIRS SPECIALIST CONTACTED THE PT'S MOTHER TO OBTAINED MORE INFO. THE PT TESTS 4 TIMES PER DAY AND CURRENTLY TAKES LANTUS AND NOVOLOG INSULIN (70 UNITS OF LANTUS DURING BEDTIME, 15 UNITS OF NOVOLOG AT BREAKFAST, 16 UNIT OF NOVOLOG AT LUNCH, 20 UNITS OF NOVOLOG AT DINNER, AND 6 UNITS OF NOVOLOG AT BEDTIME). THE PT ALSO BASES HIS NOVOLOG INSULIN INTAKE ON HIS BLOOD GLUCOSE READINGS. ON APPROX THE MONTH PRIOR TO ORIGINAL MONTH AT 6PM, THE PT NOTED HE OBTAINED THE FOLLOWING READINGS: "408, 407, 230 AND 238 MG/DL" WITH THE LIFESCAN METER. ACCORDING TO THE PT'S MOTHER, THE PT TOOK HIS NOVOLOG INSULIN BASED ON A "400 MG/DL" READING AND ATE DINNER. WITHIN 30 MINUTES, THE PT DEVELOPED SYMPTOMS DESCRIBED AS "SWEATING, LETHARGIC, UNCOORDINATED, AND WAS NOT MAKING SENSE LIKE HE WAS DRUNK." THE PT'S MOTHER DROVE THE PT TO THE HOSPITAL. UPON ARRIVAL AT 6:20 PM, THE PT WAS TESTED AT "40 MG/DL" ON ANOTHER DEVICE. HE WAS DIAGNOSED WITH HYPOGLYCEMIA AND WAS GIVEN A GLUCAGON INJECTION. THE PT'S MOTHER INDICATED THAT IT TOOK THE PT AWHILE TO RAISE HIS BLOOD GLUCOSE TO "70 MG/DL." THE PT WAS NEVER ADMITTED INTO THE HOSPITAL AND WAS DIAGNOSED WITH HYPOGLYCEMIA. THE PT'S MOTHER DOES NOT KNOW WHETHER THE DIABETES MEDICATION REGIMEN AND TESTING FREQUENCY WAS CHANGED PRIOR TO OR AFTER THE HOSPITAL INCIDENT. DURING THE TROUBLESHOOTING, THE CUSTOMER CARE ADVOCATE VERIFIED THAT THE UNIT OF MEASUREMENT WAS CORRECTLY SET TO MG/DL, THE PUNCTURE AREA WAS CLEANED APPROPRIATELY, THE TESTING TECHNIQUE IS CORRECT, AND THE ACCURACY CALCULATED DIFFERENCE WAS LESS THAN OR EQUAL TO 30 MG/DL OR 30%. HOWEVER, BASED ON THE REPORTED READING, IT WAS FOUND THAT THE CALCULATED DIFFERENCE EXCEEDS THE EXPECTED VALUE OF <=30% AND/OR <=30 MG/DL. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT CLAIMED HE WAS TREATED FOR HYPOGLYCEMIA AFTER HE TOOK INSULIN BASED ON THE METER READING. 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 17 YR Life Threatening| R