BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH LANCING DEVICE

    MDR report key: 2180624 · Received July 27, 2011

    Report

    Report Number
    2939301-2011-06498
    Event Type
    Injury
    Date Received
    July 27, 2011
    Date of Event
    June 29, 2011
    Report Date
    June 29, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH LANCING DEVICE WAS BROKEN. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE CCA WAS ADVISED BY THE PATIENT THAT ON (B)(6) 2011 AT 2:00AM, SHE DISCOVERED THE ALLEGED COCKING CONTROL ISSUE WITH THE SUBJECT BLOOD SAMPLER. THE PATIENT STATED THAT SHE MANAGES HER DIABETES WITH INSULIN, 60 UNITS OF NOVOLOG. AN HOUR AND HALF AFTER THE REPORTED ISSUE BEGAN, THE PATIENT CLAIMED TO HAVE TAKEN HER USUAL DOSE OF INSULIN IN RESPONSE TO THE ALLEGED ISSUE AND SIMULTANEOUSLY DEVELOPED SYMPTOMS OF "SWEATING AND SHAKING". THE PATIENT DENIED RECEIVING ANY TREATMENT IN RESPONSE TO THESE SYMPTOMS. AT THE TIME OF TROUBLESHOOTING, THE CCA DETERMINED THAT THE SUBJECT BLOOD SAMPLER WAS BRAND NEW, OUT OF THE BOX, AND THAT THERE WAS NO MISUSE OF THE PRODUCT. REPLACEMENT PRODUCT WAS SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMED TO HAVE DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY. IN ADDITION, THE REPORTED ISSUE WITH THE SUBJECT BLOOD SAMPLER REMAINS UNRESOLVED WITH TROUBLESHOOTING.

    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 30 YR Life Threatening