BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT DELICA LANCING DEVICE

    MDR report key: 2943470 · Received February 5, 2013

    Report

    Report Number
    3008382007-2013-02295
    Event Type
    Injury
    Date Received
    February 5, 2013
    Report Date
    January 23, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE LANCING DEVICER WAS FOUND TO FUNCTION PROPERLY. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT THE LANCET IN HER ONETOUCH DELICA LANCING DEVICE WAS NOT FULLY PENETRATING. ON (B)(6) 2013, THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE PATIENT TO OBTAIN AND VERIFY INFORMATION. THE PATIENT CLAIMED THE ALLEGED ISSUE WITH THE LANCING DEVICE BEGAN FROM THE FIRST TIME SHE STARTED USING IT APPROXIMATELY 2-3 MONTHS AGO. THE PATIENT CLAIMED THAT SHE WOULD HAVE TO PUNCTURE HER FINGERS REPEATEDLY IN ORDER TO GET A BIG ENOUGH SAMPLE OF BLOOD. SHE CLAIMED SOMETIME AT THE BEGINNING OF (B)(6) 2012, (EXACT DATE/TIME UNKNOWN) SHE HAD PUNCTURED THE SAME FINGER FOUR TIMES DUE TO THE ISSUE WHICH CAUSED HER PAIN AND SWELLING. SHE STATED SHE WENT TO A LOCAL CLINIC TO GET IT SEEN AND WAS TOLD BY THE PHYSICIAN'S ASSISTANT THAT SHE HAD "CELLULITIS", A SKIN INFECTION. THE PATIENT WAS GIVEN ANTIBIOTICS BY THE HCP THAT SHE TOOK FOR 10 DAYS, 4X DAILY. SHE STATED, THE INFECTION DID CLEAR UP AFTER 10 DAYS. NO OTHER TREATMENT OR DEVICE WAS PROVIDED. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE SUBJECT LANCING DEVICE WAS NOT BEING USED FOR THE FIRST TIME. THE PATIENT'S TESTING TECHNIQUE WAS REVIEWED BUT THE ISSUE REMAINED UNRESOLVED. THE CORRECT LANCETS WERE BEING USED. A REPLACEMENT PRODUCT WAS SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE, THE PATIENT ALLEGEDLY RECEIVED MEDICAL INTERVENTION FROM A HEALTH CARE PROFESSIONAL (HCP) AFTER THE REPORTED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48491 OT DELICA LANCING DEVICE GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Life Threatening| R