BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT DELICA LANCING DEVICE

    MDR report key: 2820779 · Received November 6, 2012

    Report

    Report Number
    2939301-2012-12757
    Event Type
    Injury
    Date Received
    November 6, 2012
    Date of Event
    October 23, 2012
    Report Date
    October 23, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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) 2012, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH DELICA LANCING DEVICE DOES NOT FULLY PENETRATE HER FINGERS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. ON (B)(6) 2012 AT 3PM, THE PATIENT REPORTED THE ALLEGED ISSUE FIRST OCCURRED. THE PATIENT REPORTED USING INSULIN PUMP THERAPY (UNKNOWN TYPE) TO MANAGE HER DIABETES. THE PATIENT REPORTED ON (B)(6) 2012 BETWEEN 3-3:45PM SHE HAD HER USUAL DOSE OF INSULIN ON A SLIDING SCALE. THE PATIENT REPORTED 30 MINUTES AFTER THE START OF THE ALLEGED ISSUE, SHE FELT 'SHAKY, AND SORE FINGERS DUE TO STICKING SEVERAL TIMES.' THE PATIENT DENIED RECEIVING ANY MEDICAL INTERVENTION FOR AN ACUTE COMPLICATION OF DIABETES. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THERE WAS NO MISUSE OF THE PRODUCT AND THIS WAS THE FIRST TIME THE PRODUCT HAD BEEN USED. THE CCA WAS ABLE TO REVIEW THE PATIENT'S TESTING TECHNIQUE, AND THE ALLEGED ISSUE WAS NOT RESOLVED WITH TRAINING. IN ADDITION, THE PATIENT WAS USING THE CORRECT LANCETS WITH A 33G. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMED DUE TO THE ALLEGED ISSUE, SHE WAS UNABLE TO OBTAIN A SAMPLE, THEREFORE DEVELOPED SYMPTOMS OF HYPOGLYCEMIA.

    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 68 YR Life Threatening