BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH LANCING DEVICE

    MDR report key: 1841805 · Received September 22, 2010

    Report

    Report Number
    2939301-2010-08302
    Event Type
    Injury
    Date Received
    September 22, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 8, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    FMK
    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. METER SERIAL #: NOT PROVIDED. LOT #: NOT PROVIDED.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE LAY USER/PATIENT IN THE (B)(6) CONTACTED LIFESCAN TO REPORT THE ONE TOUCH LANCING DEVICE WOULD NOT FIRE THE LANCET. ON SEPTEMBER 17, 2010, THE TECHNICAL SERVICE REPRESENTATIVE (TSR) SPOKE WITH THE PATIENT TO OBTAIN AND VERIFY INFORMATION; HOWEVER THE PATIENT REFUSED TO SPEAK WITH THE TSR. THE SR. MEDICAL SURVEILLANCE SPECIALIST CLASSIFIED THE COMPLAINT BASED ON THE INFORMATION PROVIDED DURING THE INITIAL TELEPHONE CALL WITH CUSTOMER SERVICE. ON APPROXIMATELY (B)(6) 2010, THE PATIENT NOTED THE REPORTED LANCING DEVICE WOULD NOT FIRE THE LANCET; SHE WAS UNABLE TO OBTAIN A BLOOD SAMPLE FOR GLUCOSE TESTING. AT AN UNSPECIFIED TIME AFTERWARDS, THE PATIENT EXPERIENCED THE SYMPTOMS OF "HYPOGLYCEMIA". THE PATIENT TOOK NO ACTIONS AND DID NOT SEEK ANY MEDICAL ATTENTION. THE PATIENT MANAGES HER DIABETES WITH INSULIN TAKEN ON A SLIDING SCALE. IT WOULD HAVE BEEN HELPFUL TO DETERMINE THE PATIENT'S SPECIFIC SYMPTOMS OF HYPOGLYCEMIA, HER DIABETES MEDICATION REGIMEN, AND WHAT MEALS AND MEDICATIONS WERE TAKEN ON THE DAY PRIOR TO THE ONSET OF SYMPTOMS. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THE LANCING DEVICE WAS REPLACED. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS OF HYPOGLYCEMIA AFTER SHE WAS UNABLE TO OBTAIN BLOOD SAMPLES FOR GLUCOSE TESTING DUE TO THE LANCING DEVICE ISSUE. 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 FMK LIFESCAN, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Life Threatening