BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRAMINI METER

    MDR report key: 1617251 · Received February 22, 2010

    Report

    Report Number
    2939301-2010-00954
    Event Type
    Injury
    Date Received
    February 22, 2010
    Date of Event
    December 16, 2009
    Report Date
    February 4, 2010
    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

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. 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

    ON (B) (6) 2010, THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING THAT THE ONE TOUCH ULTRA MINI METER READ INACCURATELY HIGH. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) CONTACTED THE PATIENT TO OBTAIN/CLARIFY INFORMATION. THE PATIENT REPORTED READINGS OF 129, 145, 136, 140, 136, 121, 149, 157, 191, 122, AND 160 MG/DL ON (B) (6) 2009 STARTING AT 10 AM. THE PATIENT PERCEIVED THOSE READINGS TO BE HIGH BECAUSE, THAT DAY HE WALKED TO THE STORE AND CAME BACK EXPECTING HIS READINGS TO BE LOWER DUE TO INCREASED ACTIVITY. SHORTLY AFTER HE CAME BACK FROM THE STORE IN THE EARLY AFTERNOON IT WAS REPORTED THAT HE FELT WEAK, SHAKING, AND TREMBLING. THE PATIENT TOOK SOME FOOD AND/OR DRINK AS TREATMENT FOR THE SYMPTOMS. HE EXPECTS READINGS OF 120 MG/DL IN THE MORNING AND SAYS IF HIS ACTIVITY IS NORMAL HIS READINGS WON'T GO DOWN. HE SAYS, HE ADJUSTS HIS INSULIN REGIME ACCORDING TO HOW HE EATS. HE SAYS HE RAISES HIS INSULIN A LITTLE IF HE EATS MORE SWEET OR GREASY FOOD. HE NORMALLY TAKES 40 UNITS OF NOVOLIN 70/30 INSULIN AT MEALS AND TAKES 43 IF HE EATS SWEET OR GREASY FOOD. THE PATIENT ALSO TAKES 45 MG OF ACTOS EVERY MORNING. HE SAYS HE ADJUSTS HIS DIET AND EXERCISE WITH HIS METER READINGS AND MARKS IT DOWN ON PAPER. ACCORDING TO THE TROUBLESHOOTING PERFORMED WITH CUSTOMER SERVICE, THE UNIT OF MEASURE WAS SET CORRECTLY AT THE TIME OF TESTING. THIS COMPLAINT IS BEING REPORTED BECAUSE, THE PATIENT ALLEGED THE METER READ INACCURATELY HIGH, INCREASED HIS ACTIVITY LEVEL, AND SUFFERED SYMPTOMS INDICATIVE OF HYPOGLYCEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2960678

    Patients

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