BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRASMART METER

    MDR report key: 1326858 · Received February 24, 2009

    Report

    Report Number
    2939301-2009-01193
    Event Type
    Injury
    Date Received
    February 24, 2009
    Report Date
    February 4, 2009
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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

    UNABLE TO SPEAK WITH THE PATIENT/LAYPERSON, THIS SENIOR MEDICAL SURVEILLANCE SPECIALIST WILL SEND A LETTER AND HAS REVIEWED THE CUSTOMER CARE ADVOCATE'S (CCA'S) DOCUMENTATION. IN 2009, THE PATIENT INFORMED A CCA THAT BLOOD GLUCOSE RESULTS WITH HER ONETOUCH ULTRASMART METER WERE ERRATIC, 181, 144, AND 160 MG/DL, ALL PERFORMED WITHIN LESS THAN 10 MINUTES. THE VARIANCE IS WITHIN THE EXPECTED LESS THAN EQUAL TO 20%. THE PATIENT TOOK NO ACTION. THE REPORTED PRODUCT ISSUE DATE WAS NOT SPECIFIC, POSSIBLY THE MONTH PRIOR. ON A DATE AND TIME NOT PROVIDED AFTER THE ISSUE BEGAN, THE PATIENT WAS NAUSEATED WITH BLURRED VISION AND CHEST PAIN. THE PATIENT, WHO TAKES NO DIABETES MEDICATION, REPORTEDLY WAS SEEN BY HER PHYSICIAN, AGAIN DATE AND TIME UNKNOWN. THE PHYSICIAN REFERRED THE PATIENT TO A CARDIOLOGIST AND A DIABETES SPECIALIST ONLY; NO TREATMENT WAS GIVEN. BECAUSE THE PATIENT ALLEGED HAVING SYMPTOMS AFTER THE ISSUE BEGAN, THE COMPLAINT IS REPORTED SINCE THE SYMPTOMS MEET THE CRITERIA FOR SERIOUS INJURY ALTHOUGH NO TREATMENT WAS GIVEN TO THE PATIENT. THE PRODUCTS WERE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRASMART METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2872709

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Life Threatening