BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH LANCING DEVICE

    MDR report key: 1951629 · Received January 6, 2011

    Report

    Report Number
    2939301-2011-00219
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    December 31, 2010
    Report Date
    January 3, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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) (B)(4) ALLEGING THAT THE LANCET HOLDER OF HER ONETOUCH LANCING DEVICE WAS DAMAGED. THE COMPLAINT WAS CLASSIFIED BASED ON ADDITIONAL INFORMATION OBTAINED BY THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DURING A FOLLOW UP CALL. THE PATIENT REPORTED THAT THE ALLEGED ISSUE WITH THE SUBJECT LANCING DEVICE BEGAN AT AN UNSPECIFIED TIME ON (B)(6), 2010. THE PATIENT INFORMED THE CSR THAT SHE TESTS HER BLOOD GLUCOSE ONCE A DAY (NO SPECIFIC TIME) AND MANAGES HER DIABETES WITH ORAL MEDICATION (TYPE UNKNOWN). THE PATIENT CLAIMED THAT AS A RESULT OF THE ALLEGED ISSUE SHE DISCONTINUED TESTING HER BLOOD GLUCOSE; HOWEVER, CONTINUED TO TAKE HER ORAL MEDICATION AS USUAL. AT AN UNSPECIFIED TIME ON (B)(6), 2010, AFTER THE ALLEGED ISSUE STARTED, THE PATIENT REPORTED THAT SHE DEVELOPED A HEADACHE AND FELT SHAKY AND TIRED. IN RESPONSE TO THE SYMPTOMS, THE PATIENT STATED SHE WENT TO THE EMERGENCY ROOM ON (B)(6), 2011. THE PATIENT CLAIMED HER BLOOD GLUCOSE WAS "20 MMOL/L (360 MG/DL)" WHEN CHECKED ON THE ER/HOSPITAL METER. THE PATIENT ALSO REPORTED THAT SHE WAS TREATED WITH INSULIN WHILE IN THE ER AND WAS DISCHARGED AFTER FEELING BETTER. PRIOR TO THE ONSET OF SYMPTOMS, THE PATIENT REPORTED THAT SHE HAD LAST TESTED HER BLOOD GLUCOSE ON (B)(6), 2010; HOWEVER, SHE WAS UNABLE TO RECALL THE RESULT OBTAINED. AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THAT THE PATIENT WAS USING THE SUBJECT LANCING DEVICE FOR APPROXIMATELY 2 MONTHS AND THAT THE PATIENT DENIED ANY MISUSE TO THE PRODUCT. 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 WAS TREATED FOR HYPERGLYCEMIA BY AN HCP AFTER THE ALLEGED LANCING DEVICE 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 56 YR Hospitalization| L| R