BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT DELICA LANCING DEVICE

    MDR report key: 2192365 · Received August 4, 2011

    Report

    Report Number
    2939301-2011-06902
    Event Type
    Injury
    Date Received
    August 4, 2011
    Report Date
    July 14, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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) TO REPORT THAT THE LANCET WOULD NOT FULLY PENETRATE WHEN SHE ATTEMPTED TO OBTAIN A BLOOD SAMPLE USING HER ONETOUCH DELICA LANCING DEVICE. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE PATIENT ON (B)(6) 2011 AND OBTAINED THE FOLLOWING INFORMATION. THE PATIENT REPORTED THAT THE ALLEGED ISSUE WITH THE SUBJECT LANCING DEVICE BEGAN AROUND "LUNCH TIME" APPROXIMATELY 3 WEEKS PRIOR TO CONTACTING LFS. SHE STATED THAT SHE MANAGES HER DIABETES WITH NOVOLIN (N AND R) AND ACTOS. DUE TO THE ALLEGED PRODUCT ISSUE APPROXIMATELY 1-2 DAYS LATER, SHE SKIPPED HER USUAL DOSE OF NOVOLIN R BECAUSE SHE DID NOT KNOW WHAT HER GLUCOSE LEVEL COULD HAVE BEEN AND MAINTAINED THE REST OF HER USUAL DIABETES TREATMENT. THE PATIENT CLAIMED THAT FROM THE TIME THE DELICA DEVICE STOPPED WORKING, PROBABLY A DAY LATER, SHE HAD BEEN URINATING FREQUENTLY AND HAD AN ULCER ON HER FEET. THE PATIENT CLAIMED THAT 2 DAYS LATER (COULD NOT RECALL EXACT TIME), AFTER THE PRODUCT ISSUE BEGAN, SHE ENDED UP IN THE EMERGENCY ROOM (ER) AND WAS TESTED WITH AN ER METER. THEY OBTAINED A GLUCOSE RESULT OF "555 MG/DL". SHE WAS GIVEN IV FLUIDS AND INSULIN BY THE HEALTH CARE PROFESSIONAL. DURING THE INITIAL CALL WITH CUSTOMER SERVICE, THE CCA NOTED THAT THERE IS NO INFORMATION OF MISUSE OF THE METER AND SHE WAS USING THE PROPER TESTING TECHNIQUE. 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 DEVELOPED SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA AND THE PATIENT ALLEGEDLY RECEIVED MEDICAL INTERVENTION FROM A HEALTH CARE PROFESSIONAL (HCP) AFTER THE REPORTED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT DELICA LANCING DEVICE GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Life Threatening| R