BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1645199 · Received March 25, 2010

    Report

    Report Number
    2939301-2010-02032
    Event Type
    Injury
    Date Received
    March 25, 2010
    Date of Event
    March 16, 2010
    Report Date
    March 19, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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/PT CONTACTED LIFESCAN ALLEGING THAT THE ONETOUCH ULTRA METER READ IMPRECISELY. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) CONTACTED THE PT TO OBTAIN/CLARIFY INFORMATION. THE PT REPORTED READINGS OF 216, 196, 192, 158, AND 101 MG/DL PERFORMED GREATER THAN 20 MINUTES APART FROM EACH OTHER. SHE REPORTED ONE INSTANCE ON (B) (6) AT 5 PM DURING WHICH SHE OBTAINED A READING OF 247 MG/DL, ATE SOME SALAD, CHEESE, AND A PIECE OF HAM FOR A MEAL AND HAD A READING OF 147 MG/DL AND HOUR AFTER THE 247 MG/DL READING. SHE SAYS THAT DUE TO THE ELEVATED 247 MG/DL READING, SHE ATE LESS THAN WHAT SHE NORMALLY WOULD HAVE EATEN. SHE SAID SHE HADN'T EATEN TOO MUCH THAT DAY IN GENERAL AND HAD SYMPTOMS OF LIGHTHEADEDNESS AND SHAKINESS AROUND THE TIME OF THE 147 MG/DL READING. THE PT DOES NOT TAKE ANY MEDICATIONS FOR DIABETES AND MANAGES HER DIABETES THROUGH DIET AND EXERCISE. THE PT TESTS HER BLOOD SUGAR TWICE DAILY. 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 PT ALLEGED THE METER WAS READING INACCURATELY, ATE LESS FOOD BASED ON THE READINGS, AND SUFFERED SYMPTOMS THAT MAY BE INDICATIVE OF HYPOGLYCEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2881915

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening| R