BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT DELICA LANCING DEVICE

    MDR report key: 2190233 · Received August 4, 2011

    Report

    Report Number
    2939301-2011-06828
    Event Type
    Injury
    Date Received
    August 4, 2011
    Report Date
    July 13, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 SHE WAS EXPERIENCING AN ALLEGED LANCING DEVICE ISSUE WITH HER ONETOUCH DELICA LANCING DEVICE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE CCA WAS ADVISED BY THE PATIENT THAT AT AN UNSPECIFIED DATE AND TIME ON (B)(6) 2011, THE LANCET ON THE SUBJECT BLOOD SAMPLER ALLEGEDLY WAS "HARD TO INSERT/REMOVE". IT IS NOT KNOWN IF THE PATIENT TAKES ANY MEDICATION TO MANAGE HER DIABETES OR IF SHE MADE ANY CHANGES TO HER NORMAL DIABETES MANAGEMENT ROUTINE IN RESPONSE THE ALLEGED ISSUE. AT AN UNKNOWN DATE AFTER THE REPORTED ISSUE BEGAN UNTIL THE PRESENT TIME, THE PATIENT CLAIMED TO HAVE DEVELOPED SYMPTOMS OF "SWEATING" BUT DENIED RECEIVING ANY MEDICAL TREATMENT IN RESPONSE TO THE SYMPTOMS. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE PATIENT WAS A FIRST TIME USER OF THE SUBJECT BLOOD SAMPLER AND BECAUSE THE PATIENT DID NOT HAVE HER EYEGLASSES AVAILABLE TO USE AND WAS HARD OF SEEING, SHE WAS NOT ABLE TO GO THROUGH ANY TROUBLESHOOTING. PER THE CCA, NO REPLACEMENT PRODUCTS WILL BE SENT AT THIS TIME. THE PATIENT WILL CALL BACK AT A LATER TIME. ALTHOUGH THE PATIENT DENIED RECEIVING ANY MEDICAL TREATMENT, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY.

    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 Life Threatening