BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT DELICA LANCING DEVICE

    MDR report key: 3211025 · Received July 8, 2013

    Report

    Report Number
    3008382007-2013-19096
    Event Type
    Injury
    Date Received
    July 8, 2013
    Report Date
    June 10, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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) 2013 THE LAY USER/REPORTER CONTACTED LIFESCAN (LFS) ALLEGING THE PATIENT¿S ONETOUCH DELICA LANCETS WERE NOT FITTING IN THE LANCING DEVICE . THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE REPORTER STATED THE ALLEGED ISSUE FIRST OCCURRED ON (B)(6) 2013 IN THE AFTERNOON. THE REPORTER STATED THE PATIENT USES SELF ADJUSTING INSULIN TO MANAGE HIS DIABETES AND HE NORMALLY TESTS MORE THAN 4 TIMES A DAY. THE REPORTER STATED ON (B)(6) 2013 AT 4:30PM THE PATIENT WAS GIVEN 8 UNITS OF SHORT ACTING INSULIN BY A THIRD PARTY WHO WAS NOT A HEALTHCARE PROFESSIONAL. THE REPORTER STATED ON (B)(6) 2013 AT 5PM, THE PATIENT HAD LESS TO EAT OR DRINK. THE REPORTER STATED THE PATIENT DID NOT DEVELOP ANY SYMPTOMS. THE REPORTER STATED NO OTHER DEVICE WAS USED TO MEASURE THE PATIENT¿S BLOOD GLUCOSE. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THERE WAS NO MISUSE OF THE PRODUCT AND THIS WAS THE FIRST TIME THE LANCING DEVICE HAD BEEN USED. THE PATIENT WAS FOUND TO BE USING THE CORRECT LANCETS. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTER STATED DUE TO THE ALLEGED ISSUE, THE PATIENT REQUIRED ASSISTANCE FROM A THIRD PARTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310959 OT DELICA LANCING DEVICE GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Life Threatening| R