BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT DELICA LANCING DEVICE

    MDR report key: 2883597 · Received December 21, 2012

    Report

    Report Number
    3008382007-2012-08796
    Event Type
    Injury
    Date Received
    December 21, 2012
    Report Date
    December 7, 2012
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Removal / Correction Number
    2939301-05/10/11-001C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY USER/PATIENT CONTACTED LFS ALLEGING AN ISSUE WITH HER ONETOUCH DELICA LANCING DEVICE. THE PATIENT REPORTED THAT THE LANCET WAS HARD TO REMOVE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION, SINCE THE PATIENT WAS UNABLE TO BE REACHED BY PHONE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE ISSUE. THE PATIENT REPORTED THAT THE ALLEGED LANCING DEVICE ISSUE BEGAN A FEW WEEKS PRIOR TO CONTACTING LFS. IT IS NOT CLEAR WHAT DIFFICULTY THE PATIENT WAS HAVING WITH REMOVING THE LANCET FROM THE LANCING DEVICE. THE ONETOUCH DELICA LANCING DEVICE FEATURES A HANDS-FREE LANCET EJECTION. IT IS NOT KNOWN IF THE PATIENT WAS EXPERIENCING A PROBLEM WITH THE EJECTOR MECHANISM. AT THE TIME OF THE CALL, THE PATIENT STATED THAT SOMEONE THAT WAS HELPING HER REMOVE THE LANCET ACCIDENTALLY 'POKED HERSELF WITH THE LANCET.' NO ADDITIONAL INFORMATION REGARDING THE INCIDENT WAS PROVIDED. IT IS NOT KNOWN IF THE PERSON RECEIVED AN UNINTENTIONAL FINGERSTICK WITH A USED LANCET. IT IS ALSO NOT KNOWN IF THE PERSON RECEIVED FIRST AID OR MEDICAL INTERVENTION AS A RESULT OF THE UNINTENTIONAL PRICK WITH THE LANCET. PER THE INSTRUCTIONS FOR USE, THE USER IS INSTRUCTED TO COVER THE NEEDLE PRIOR TO EJECTING THE LANCET USING THE EJECTOR MECHANISM. IT IS NOT KNOWN IF THE LANCET WAS COVERED USING THE LANCET PROTECTIVE COVER PRIOR TO ATTEMPTING TO REMOVE LANCET. AT THE TIME OF TROUBLESHOOTING, THE CSR CONFIRMED THE PATIENT WAS USING THE CORRECT LANCETS. THE ALLEGED PRODUCT ISSUE REMAINED UNRESOLVED. THIS COMPLAINT IS BEING REPORTED BECAUSE LFS COULD NOT RULE OUT THAT THE ALLEGED LANCING DEVICE ISSUE CAUSED AND/OR CONTRIBUTED TO A SERIOUS INJURY. IT COULD NOT BE CONFIRMED IF THE USER REQUIRED MEDICAL INTERVENTION FOR OR TO PREVENT A SYSTEMIC INFECTION AS A RESULT OF THE UNINTENTIONAL NEEDLESTICK INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Life Threatening