BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT DELICA LANCING DEVICE

    MDR report key: 2428230 · Received January 25, 2012

    Report

    Report Number
    2939301-2012-00938
    Event Type
    Injury
    Date Received
    January 25, 2012
    Report Date
    December 28, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Removal / Correction Number
    2939301-05/10/11-001C
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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) 2011, THE HEALTH SERVICES DIRECTOR OF HOME AND COMMUNITY OPTIONS INC, AN ADULT SERVICES FACILITY FOR THE DEVELOPMENTALLY DISABLED, CONTACTED LIFESCAN (LFS) TO REPORT THAT TWO EMPLOYEES AT THEIR FACILITY WERE ACCIDENTALLY PRICKED WITH A ONETOUCH DELICA LANCING DEVICE AS A RESULT OF THE LANCETS BEING HARD TO REMOVE. ON (B)(6) 2012, THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH ONE OF THE CENTER DIRECTORS TO OBTAIN ADDITIONAL INFORMATION. THE REPORTER INFORMED THE MSS THAT THE ALLEGED INCIDENTS OCCURRED ON TWO SEPARATE OCCASIONS, BUT SHE DID NOT KNOW EXACT DATES/TIMES. SHE REPORTED THAT AFTER A PATIENT'S BLOOD GLUCOSE WAS CHECKED, AN EMPLOYEE WAS ATTEMPTING TO REMOVE THE USED LANCET FROM THE SUBJECT LANCING DEVICE WHEN HE/SHE WAS ACCIDENTALLY PRICKED WITH THE LANCET. THE SUBJECT LANCING DEVICE BELONGS TO THE PATIENT. THE REPORTER CLAIMED THE SAME THING HAD ALSO OCCURRED WITH ANOTHER STAFF MEMBER WHEN TESTING THE SAME PATIENT ON A DIFFERENT OCCASION. TROUBLESHOOTING REVEALED THAT THE STAFF WAS NOT FOLLOWING THE MANUFACTURER'S INSTRUCTIONS ON HOW TO CORRECTLY REMOVE A LANCET FROM THE LANCING DEVICE. AFTER TESTING THE PATIENT, THE STAFF WAS MANUALLY PLACING THE PROTECTIVE DISK BACK ON THE NEEDLE, BUT IT WASN'T SECURE. THE LANCING DEVICE WAS COCKED BACK, AND THE "RELEASE" BUTTON WAS PRESSED. BOTH EMPLOYEES WERE REFERRED TO A PHYSICIAN ON UNSPECIFIED DATES/TIMES FOR MEDICAL ATTENTION. IT IS NOT KNOWN WHAT FORM OF TREATMENT WAS ADMINISTERED AND IT IS NOT KNOWN HOW MUCH TIME ELAPSED BETWEEN THE REPORTED INJURIES AND THE MEDICAL INTERVENTION. THE CCA EDUCATED THE REPORTER ON THE CORRECT PROCEDURE FOR SAFE REMOVAL OF THE LANCET. PER THE DELICA QUICK START GUIDE, THE ONETOUCH DELICA LANCING DEVICE FEATURES HANDS-FREE LANCET EJECTION. TO USE THIS FEATURE, THE USER IS ASKED TO PLACE THE LANCET COVER ON A HARD SURFACE. THEN, WITH THE USED LANCET STILL IN THE DEVICE, PUSH THE LANCET NEEDLE INTO THE CUPPED SIDE OF THE COVER. THE COVER WILL SNAP FIRMLY IN PLACE AND THE LANCET CAN THEN BE SAFELY EJECTED USING THE "EJECTOR" BUTTON. THE REPORTER INFORMED THIS MSS THAT THE STAFF HAS BEEN RE-TRAINED ON THE CORRECT PROCEDURE FOR SAFE REMOVAL OF LANCETS. REPLACEMENT PRODUCT WAS SENT TO THE ACCOUNT. THIS COMPLAINT IS BEING REPORTED BECAUSE TWO STAFF MEMBERS REQUIRED MEDICAL OR THIRD PARTY INTERVENTION AS A RESULT OF POSSIBLY BEING EXPOSED TO BLOOD-BORNE PATHOGEN DUE TO UNINTENTIONAL LANCET PRICK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening