BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1261251 · Received December 8, 2008

    Report

    Report Number
    2939301-2008-03512
    Event Type
    Injury
    Date Received
    December 8, 2008
    Date of Event
    November 21, 2008
    Report Date
    November 24, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 AFFAIRS SPECIALIST REVIEWED THE CUSTOMER CARE ADVOCATE'S (CCA'S) DOCUMENTATION. A LETTER HAS BEEN SENT TO THE PATIENT. THE PATIENT REPORTEDLY OBSERVED MISSING SEGMENTS IN HER ONETOUCH ULTRA'S DISPLAY IN 2008. THE PT REPORTEDLY HAD "HIGH BLOOD SUGAR" (EXACT SYMPTOMS NOT PROVIDED) AT 10.00 AM, THE NEXT DAY. THE PATIENT REPORTEDLY INJECTED 12 UNITS (2 EXTRA) OF HUMALOG. THE PATIENT DID NOT INDICATE WHETHER SHE HAD ATTEMPTED TO TEST AFTER THE SYMPTOMS BEGAN. NO MEDICAL INTERVENTION FROM ANOTHER PERSON OR AN HCP WAS REQUIRED. THE CCA REPLACED THE METER. BECAUSE THE PATIENT ALLEGEDLY HAD UNKNOWN SYMPTOMS RELATED TO ELEVATED BLOOD GLUCOSE AFTER THE REPORTED ISSUE BEGAN, THE COMPLAINT IS REPORTED AS AN MDR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2851786

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Life Threatening