BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH LANCING DEVICE

    MDR report key: 2030054 · Received March 25, 2011

    Report

    Report Number
    2939301-2011-02641
    Event Type
    Injury
    Date Received
    March 25, 2011
    Date of Event
    March 12, 2011
    Report Date
    March 14, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT THE LANCET HOLDER ON HIS ONETOUCH LANCING DEVICE WAS DAMAGED. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE LAY USER/PATIENT ON (B)(6) 2011 AND OBTAINED THE FOLLOWING INFORMATION: THE PATIENT TESTS THREE TO FOUR TIMES A DAY AND MANAGES HIS DIABETES WITH 1000MG OF METFORMIN. THE PATIENT CONFIRMED THAT THE ALLEGED ISSUE BEGAN ON (B)(6) 2011. THE PATIENT DENIED TAKING ANY ACTION IN REGARDS TO HIS DIABETES MANAGEMENT AFTER THE REPORTED PRODUCT ISSUE OCCURRED. AS A RESULT OF THE ALLEGED ISSUE, THE PATIENT CLAIMED HE DEVELOPED A SYMPTOM OF SHAKING ONE HOUR LATER. THE PATIENT CORRECTED AND CLARIFIED AS TREATMENT, HE CONSUMED A COOKIE AND DRANK JUICE IMMEDIATELY AFTER THE ONSET OF HIS SYMPTOM AND FELT HIS SYMPTOM IMPROVED APPROXIMATELY THIRTY MINUTES LATER. AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THAT THE PATIENT WAS NOT USING THE SUBJECT LANCING DEVICE FOR THE FIRST TIME AND THERE WAS NO MISUSE OF THE LFS PRODUCT. A REPLACEMENT LANCING DEVICE WAS SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS HE WAS UNABLE TO TEST HIS BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND REPORTEDLY DEVELOPED A SYMPTOM SUGGESTIVE OF HYPOGLYCEMIA AFTER THE ALLEGED 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 63 YR Life Threatening| R