BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT DELICA LANCING DEVICE

    MDR report key: 2982006 · Received February 28, 2013

    Report

    Report Number
    3008382007-2013-03932
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    February 15, 2013
    Report Date
    February 17, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP (4/2/2013)-DEVICE EVALUATION: THE LFS LANCING DEVICE INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE LFS LANCING DEVICE HAS PASSED TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE REPRODUCED. 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 THE LANCET DOES NOT FULLY PENETRATE ON HER ONETOUCH DELICA LANCING DEVICE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN ON (B)(6) 2013, AT 1PM. THE PATIENT DOES NOT TAKE MEDICATIONS TO MANAGE HER DIABETES AND CONTINUED TO FOLLOW HER USUAL MANAGEMENT ROUTINE. ON THE FOLLOWING DAY, THE PATIENT CLAIMS SHE FELT SYMPTOMS OF DIZZINESS, LIGHT HEADED AND SHAKINESS. THE PATIENT DENIED RECEIVING MEDICAL TREATMENT. THE CORRECT LANCETS WERE BEING USED AND THERE WAS NO INDICATION OF MISUSE. THE ALLEGED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. A REPLACEMENT LANCING DEVICE WAS SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER NOT BEING ABLE TO TEST DUE TO THE LANCING DEVICE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87616 OT DELICA LANCING DEVICE GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Life Threatening