BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 1243812 · Received November 24, 2008

    Report

    Report Number
    2939301-2008-03224
    Event Type
    Injury
    Date Received
    November 24, 2008
    Date of Event
    June 30, 1905
    Report Date
    November 17, 2008
    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

    IN 2008, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRA2 METER WAS PROMPTING "APPLY BLOOD" AFTER A SAMPLE HAD BEEN APPLIED TO THE TEST STRIP. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE REPORTER STATED THAT THE ALLEGED ISSUE BEGAN APPROXIMATELY ONE MONTH PRIOR TO CONTACTING LFS. ON AN UNSPECIFIED DATE/TIME, THE PATIENT CLAIMED SHE GUESSED HOW MUCH INSULIN TO TAKE (5-8 UNITS EXTRA OF 70/30 INSULIN) AS A RESULT OF NOT BEING ABLE TO OBTAIN A BLOOD GLUCOSE READING. SOMETIME AFTER ADMINISTERING THE INSULIN, THE PATIENT REPORTED THAT SHE SUFFERED FROM A LOW BLOOD SUGAR (BECAME SWEATY) AND HAD TO TAKE GLUCOSE TABLETS TO BRING HER BLOOD SUGAR UP. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THE PATIENT WAS USING THE CORRECT TESTING TECHNIQUE. THE ISSUE REMAINED UNRESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE DUE TO THE REPORTED ISSUE, AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2855609

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Life Threatening| R