BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH LANCING DEVICE

    MDR report key: 1844447 · Received September 25, 2010

    Report

    Report Number
    2939301-2010-08445
    Event Type
    Injury
    Date Received
    September 25, 2010
    Date of Event
    August 25, 2010
    Report Date
    September 3, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    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

    ON (B)(6), 2010, THE LAY USER/PATIENT CONTACTED LIFESCAN TO REPORT THE ONE TOUCH LANCING DEVICE HAD A COCKING CONTROL ISSUE. ON (B)(6), 2010, THE SR. MEDICAL SURVEILLANCE SPECIALIST CONTACTED THE PATIENT TO OBTAIN AND VERIFY INFORMATION; HOWEVER WAS UNABLE TO REACH HIM BY TELEPHONE. ON (B)(6), 2010, THE PATIENT NOTED THERE WAS A COCKING CONTROL ISSUE WITH THE REPORTED LANCING DEVICE; HE WAS UNABLE TO OBTAIN A BLOOD SAMPLE FOR GLUCOSE TESTING. IMMEDIATELY AFTERWARDS, THE PATIENT EXPERIENCED THE SYMPTOMS OF "HIGH BLOOD SUGAR" LEVELS. THE PATIENT NOTED HE WENT TO THE EMERGENCY ROOM TO HAVE HIS BLOOD GLUCOSE LEVEL TESTED, WITH RESULTS OF 150 MG/DL, 300 MG/DL AND 400 MG/DL. THE PATIENT WAS TREATED WITH FIVE TO TEN UNITS HUMALOG INSULIN. IT WOULD HAVE BEEN HELPFUL TO DETERMINE THE PATIENT'S SPECIFIC SYMPTOMS OF HYPERGLYCEMIA, HIS EXPECTED BLOOD GLUCOSE READINGS, HIS MEDICATION REGIMEN AND WHAT MEALS AND MEDICATIONS HAD BEEN TAKEN PRIOR TO THE ONSET OF SYMPTOMS. THE LANCING DEVICE WAS REPLACED. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS OF HYPERGLYCEMIA AFTER HE WAS UNABLE TO TEST HIS BLOOD GLUCOSE LEVELS DUE TO THE LANCING DEVICE ISSUE, AND RECEIVED TREATMENT WITH INSULIN. THEREFORE THIS COMPLAINT IS BEING REPORTED.

    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 45 YR Life Threatening| R