BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT DELICA LANCING DEVICE

    MDR report key: 2012513 · Received March 9, 2011

    Report

    Report Number
    2939301-2011-02042
    Event Type
    Injury
    Date Received
    March 9, 2011
    Date of Event
    February 9, 2011
    Report Date
    February 10, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH LANCET IS HARD TO INSERT AND/OR REMOVE FROM THE ONETOUCH DELICA LANCING DEVICE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE BEGAN ON (B)(6) 2011 AT AN UNKNOWN TIME. THE PATIENT CLAIMED SHE MANAGES HER DIABETES WITH INSULIN. AS A RESULT OF THE ALLEGED ISSUE, THE PATIENT DENIED TAKING ANY ACTION REGARDING HER DIABETES MANAGEMENT. THE PATIENT REPORTED 10 MINUTES AFTER THE ALLEGED ISSUE BEGAN, SHE DEVELOPED SYMPTOMS OF SWEATING. IN SPITE OF THE SYMPTOM, THE PATIENT DENIED RECEIVING ANY MEDICAL TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE PATIENT WAS NOT A NEW USER TO THE LANCING DEVICE AND THERE WAS NO MISUSED OF THE DEVICE. THE ALLEGED ISSUE WAS RESOLVED THROUGH TRAINING. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT SHE DEVELOPED A SYMPTOM THAT CAN BE ASSOCIATED WITH A SERIOUS INJURY AFTER THE ALLEGED 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 66 YR Life Threatening