BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH LANCING DEVICE

    MDR report key: 1914325 · Received December 3, 2010

    Report

    Report Number
    2939301-2010-10497
    Event Type
    Injury
    Date Received
    December 3, 2010
    Report Date
    November 17, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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) 2010, A HEALTHCARE PROFESSIONAL CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING AN ISSUE WITH A PATIENT'S ONETOUCH DELICA LANCING DEVICE. IT WAS REPORTED THAT THE LANCING DEVICE'S EJECTOR CONTROL WAS NOT RESPONDING. THE COMPLAINT WAS CLASSIFIED BASED ON ADDITIONAL INFORMATION OBTAINED BY THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DURING A FOLLOW-UP CALL. APPROXIMATELY 1 WEEK PRIOR TO LFS BEING CONTACTED REGARDING THE ISSUE, A NURSE WAS TEACHING A PATIENT HOW TO USE THE SUBJECT LANCING DEVICE TO OBTAIN A BLOOD SAMPLE. THE NURSE INFORMED THE CSR THAT AFTER SHOWING THE PATIENT HOW TO PRICK HIM OR HERSELF, SHE COVERED THE LANCET WITH THE LANCET CAP AND ATTEMPTED TO EJECT THE LANCET USING THE EJECTION MECHANISM; HOWEVER, THE EJECTION CONTROL DID NOT RESPOND. THE NURSE THEN PROCEEDED WITH MANUALLY REMOVING THE LANCET WITH HER HAND. AS SHE WAS PULLING THE LANCET OUT, THE NURSE STATED THAT THE LANCET CAP CAME OFF AND SHE PRICKED HERSELF WITH A USED LANCET. THE NURSE CLAIMED SHE CONTACTED OCCUPATIONAL HEALTH, PER PROCEDURE, AND ON (B)(6) 2010 SHE WAS TESTED FOR (B)(6). THE RESULTS OF THOSE TESTS ARE NOT KNOWN. AT THE TIME OF THE FOLLOW-UP CALL, THE NURSE REPORTED THAT THE PATIENT SHE WAS EDUCATING KEPT THE SUBJECT LANCING DEVICE. THE CSR WAS UNABLE TO TROUBLESHOOT THE ALLEGED ISSUE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE NURSE REQUIRED MEDICAL OR THIRD PARTY INTERVENTION AS A RESULT OF BEING EXPOSED TO A PATIENT'S BLOOD SAMPLE AFTER THE ALLEGED ISSUE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH LANCING DEVICE GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R