BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT DELICA LANCING DEVICE

    MDR report key: 3072151 · Received April 23, 2013

    Report

    Report Number
    3008382007-2013-08701
    Event Type
    Injury
    Date Received
    April 23, 2013
    Date of Event
    April 13, 2013
    Report Date
    April 12, 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
    AL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT THE LANCET IN HIS ONETOUCH DELICA LANCING DEVICE WAS NOT FULLY PENETRATING. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT CLAIMED THE ALLEGED ISSUE WITH THE LANCING DEVICE BEGAN APPROXIMATELY 1-2 MONTHS AGO. THE PATIENT REPORTEDLY MANAGES HIS DIABETES WITH AN UNKNOWN FIXED DOSE OF INSULIN AND CONTINUED WITH HIS USUAL DIABETES MANAGEMENT ROUTINE IN RESPONSE TO THE ALLEGED ISSUE. THE PATIENT DENIED DEVELOPING SYMPTOMS AS A RESULT OF THE ALLEGED ISSUE BUT CLAIMED HE WENT TO SEE HIS DOCTOR ON (B)(6) 2013 AT 9:30AM FOR AN UNKNOWN REASON. HIS DOCTOR REPORTEDLY CHECKED HIS BLOOD GLUCOSE AND OBSERVED A VALUE OF ">300MG/DL" AND TREATED THE PATIENT WITH AN UNKNOWN TYPE AND DOSE OF INSULIN AFTER TESTING. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE SUBJECT LANCING DEVICE WAS NOT BEING USED FOR THE FIRST TIME. THE PATIENTS TESTING TECHNIQUE WAS REVIEWED BUT THE ISSUE REMAINED UNRESOLVED. THE PATIENT HAD BEEN USING THE SUBJECT LANCING DEVICE FOR APPROXIMATELY 1 MONTH PRIOR TO THE ALLEGED ISSUE OCCURRING. THE CORRECT LANCETS WERE BEING USED. A REPLACEMENT LANCING DEVICE WAS SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY RECEIVED MEDICAL INTERVENTION FROM A HEALTH CARE PROFESSIONAL (HCP) FOR AN ACUTE COMPLICATION OF DIABETES AFTER THE REPORTED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173368 OT DELICA LANCING DEVICE GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Life Threatening| R