BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH LANCING DEVICE

    MDR report key: 2020830 · Received March 16, 2011

    Report

    Report Number
    2939301-2011-02297
    Event Type
    Injury
    Date Received
    March 16, 2011
    Report Date
    February 28, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING AN UNKNOWN ONETOUCH LANCING DEVICE WAS NOT PENETRATING HER FINGER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE BEGAN LAST YEAR AT AN UNKNOWN DATE/TIME PRIOR TO CONTACTING LFS. AS PART OF HER DIABETES REGIMEN, THE PATIENT INDICATED SHE IS ON ORAL MEDICATIONS OF GLIPIZIDE PILLS 3X DAILY. DUE TO THE ALLEGED ISSUE, THE PATIENT STATED SHE ADMINISTERED ONLY 2 PILLS INSTEAD OF 3. A FEW MINUTES AFTER THE ALLEGED ISSUE BEGAN, THE PATIENT WAS FEELING STRESSED. AS A RESULT OF THE ALLEGED ISSUE, THE PATIENT INDICATED SHE WAS TAKEN TO THE EMERGENCY ROOM (ER) FOR ASSISTANCE. ACCORDING TO THE PATIENT, SHE WAS TESTED WITH A "38 MG/DL" READING BY THE ER/HOSPITAL METER AND WAS THEN ADMINISTERED "SUGAR SHOT" AND AN UNKNOWN DRINK TO RAISE HER BLOOD SUGAR LEVELS. AT THE TIME OF TROUBLESHOOTING, THE CCA WAS NOT ABLE TO RESOLVE THE ALLEGED ISSUE. REPLACEMENT PRODUCT WAS SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY RECEIVED MEDICAL INTERVENTION FROM A HEALTH CARE PROFESSIONAL (HCP) AFTER THE REPORTED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH LANCING DEVICE GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention