BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 1465124 · Received September 4, 2009

    Report

    Report Number
    2939301-2009-05546
    Event Type
    Injury
    Date Received
    September 4, 2009
    Report Date
    August 27, 2009
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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

    THE MEDICAL SURVEILLANCE SPECIALIST (MSS) CLASSIFIED THIS COMPLAINT BASED ON CUSTOMER SERVICE REP (CSR) DOCUMENTATION. THE LAY USER/PT CONTACTED LIFESCAN (LFS) CUSTOMER SERVICE ON AUGUST 27, 2009 ALLEGING THAT HER ONETOUCH ULTRA2 METER WAS READING INACCURATELY HIGH COMPARED TO HER NORMAL READINGS. SHE REPORTED BLOOD GLUCOSE RESULTS OF "178, 279, 124, 126, 177, 155, 171, 152, 179, 146, 160, 140 MG/DL," WHICH WERE REPORTED TO BE INACCURATE HIGH. AS A RESULT OF THE METER READINGS, THE PT CLAIMED SHE WAS EATING LESS THAN NORMAL, BUT CONTINUED TO TAKE HER USUAL DOSE OF ORAL DIABETES MEDICATIONS. THE PT CLAIMED THAT APPROXIMATELY 3 DAYS AFTER THE ALLEGED ISSUE BEGAN SHE FELT HYPOGLYCEMIC WITH SYMPTOMS OF SHAKING, SWEATING, AND NAUSEA. IT IS UNK IF THE PT TESTED DURING THESE SYMPTOMS IF SHE TREATED THESE SYMPTOMS. ACCORDING TO THE TROUBLESHOOTING PERFORMED WITH CUSTOMER SERVICE, THE CORRECT TESTING/CLEANING TECHNIQUES WERE USED. REPLACEMENT PRODUCTS WERE STILL SENT TO THE PT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT ALLEGEDLY DEVELOPED HYPOGLYCEMIC SYMPTOMS 3 DAYS AFTER SHE STARTED TO OBTAIN ALLEGED HIGH METER READINGS. THE PT INDICATED THAT SHE WAS EATING LESS THAN NORMAL AS A RESULT OF THE METER READINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2905422

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Life Threatening