BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRASOFT LANCING DEVICE

    MDR report key: 1013126 · Received March 14, 2008

    Report

    Report Number
    2939301-2008-00286
    Event Type
    Injury
    Date Received
    March 14, 2008
    Date of Event
    February 12, 2008
    Report Date
    February 12, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    FMK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT DEVICE FOR EVALUATION, BUT HAS NOT YET RECEIVED IT. IF THE DEVICE IS RETURNED, LIFESCAN WILL EVALUATE IT AND, IF IT DOES NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE LAY USER/PATIENT'S DAUGHTER CONTACTED LIFESCAN (LFS) IN 2008 AND ALLEGED THAT THE LANCET FROM HER MOTHER'S ONE TOUCH ULTRASOFT LANCING DEVICE WAS NOT FULLY PENETRATING. THE MEDICAL AFFAIRS SPECIALIST (MAS) CALLED AND SPOKE WITH THE PATIENT ON THE FOLLOWING MONTH AND OBTAINED ADDITIONAL INFORMATION. THE PATIENT INFORMED THE MAS THAT SHE TESTS HER BLOOD GLUCOSE 3-4 TIMES/DAY. SHE IS ON AN INSULIN REGIMENT WITH "A 70/30" INSULIN AND TAKES 40 UNITS IN THE ARM AND 40 UNITS IN THE PM. SHE ALSO REPORTED THAT THE ISSUE WITH THE LANCING DEVICE/LANCET FIRST OCCURRED IN THE MORNING OF ORIGINAL DATE (THE SAME DAY THE DAUGHTER CALLED LFS TO REPORT THE ISSUE) WHEN THE PT HAD ATTEMPTED TO TEST HER BLOOD GLUCOSE AROUND 9:00 AM. PER THE PATIENT, SINCE SHE COULD NOT USE THE "PEN", SHE DID NOT TEST HER BLOOD GLUCOSE, NOR TOOK HER SET AMOUNT OF 40 UNITS OF INSULIN. "SOMETIME" AFTER THAT, SHE EXPERIENCED WEAKNESS AND SHAKINESS AND TREATED THOSE SYMPTOMS WITH FOOD AND FELT BETTER. SHE DID NOT REQUIRE MEDICAL ATTENTION AND WAS NOT TESTED ON ANY OTHER DEVICE. THE DAUGHTER CALLED LFS THAT EVENING. AT THE TIME OF TROUBLESHOOTING, IT WAS VERIFIED THAT THIS WAS NOT A NEW PRODUCT. THE PATIENT WAS USING A REGULAR CAP AND HAD THE APPROPRIATE DEPTH SETTING. SHE WAS ALSO USING THE PRODUCT ACCORDING TO INSTRUCTIONS. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AFTER THE REPORTED ISSUE BEGAN. SHE TREATED SELF WITH FOOD AND FELT BETTER. THE ALLEGED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. REPLACEMENT PRODUCT WAS SENT TO THE LAY USER/PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRASOFT LANCING DEVICE GLUCOSE MONITORING SYS/KIT FMK LIFESCAN, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Life Threatening