BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRASMART METER

    MDR report key: 1243820 · Received November 24, 2008

    Report

    Report Number
    2939301-2008-03214
    Event Type
    Injury
    Date Received
    November 24, 2008
    Date of Event
    November 7, 2008
    Report Date
    November 12, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVAL. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IN /2008, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRASMART METER WAS READING INACCURATELY ERRATIC. THE MEDICAL AFFAIRS SPECIALIST (MAS) SPOKE WITH THE PT ON 11/19/2008 AND OBTAINED THE FOLLOWING INFO. ON 11/7/2008, BETWEEN 11:30-12:00 PM, THE PT REPORTED OBTAINING BLOOD GLUCOSE READINGS OF "376 AND 450 MG/DL" WITH THE SUBJECT METER, PERFORMED WITHIN A FEW MINUTES OF EACH OTHER. ALTHOUGH THE PT THOUGHT THE RESULTS WERE UNUSUALLY HIGH (GENERALLY OBTAINS READINGS IN THE "80-120 MG/DL" RANGE), SHE STILL BOLUSED APPROX 4 1/2 UNITS OF HUMALOG. APPROX 25 MINUTES AFTER BOLUSING, THE PT CLAIMED SHE DEVELOPED SYMPTOMS OF CONFUSION, SWEATING, AND SHAKING. AT THE ONSET OF THE SYMPTOMS, THE PT STATED HER SISTER NOTICED SHE WAS NOT FEELING WELL AND TESTED THE PT WITH THE SUBJECT METER MULTIPLE TIMES AND OBTAINED READINGS OF "35, 398, AND 73 MG/DL." THE READINGS WERE TAKEN WITHIN 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. AFTER OBTAINING THE ALLEGED ERRATIC READINGS, THE PT STATED THAT HER SISTER TREATED HER WITH FOOD, JUICE, AND GLUCOSE TABLETS AND REPORTEDLY FELT BETTER AFTERWARDS. REPLACEMENT PRODUCTS WERE SENT TO THE PT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT CLAIMS SHE OBTAINED AN INACCURATE HIGH READING ON THE SUBJECT METER, ADMINISTERED TREATMENT BASED ON THE ALLEGED RESULT, AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R