BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH LANCING DEVICE

    MDR report key: 1884295 · Received October 27, 2010

    Report

    Report Number
    2939301-2010-09531
    Event Type
    Injury
    Date Received
    October 27, 2010
    Report Date
    October 20, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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

    THE LAY USER /PATIENT CONTACTED LFS (B)(4) ON (B)(6) 2010 ALLEGING THAT HER LANCET HOLDER WAS DAMAGED ON HER ONE TOUCH MINI LANING DEVICE. THE PATIENT HAS HAD THE PRODUCT FOR 2 YEARS, PRIOR TO THE ALLEGED REPORTED ISSUE. THE PATIENT DOES NOT RECALL WHEN SHE FIRST NOTICED THAT THE LANCET HOLDER WAS DAMAGED. THE PATIENT MENTIONED THAT SINCE IT WAS DAMAGED, SHE HAD STOPPED ATTEMPTING TO TEST HER BLOOD GLUCOSE. SOMETIME LAST WEEK AT AN UNSPECIFIED DATE AND TIME, SHE DEVELOPED SYMPTOMS OF FEELING THIRSTY AND FREQUENT URINATION, WHICH SHE ASSOCIATES WITH HIGH BLOOD GLUCOSE LEVEL. SHE DID NOT SEEK ANY MEDICAL ATTENTION OR SELF-TREAT DUE TO THE ALLEGED ISSUE. THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT SHE DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER NOT BEING ABLE TO TEST DUE TO A DAMAGED LANCET HOLDER ON HER ONE TOUCH MINI LANCING DEVICE.

    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 55 YR Life Threatening