BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH LANCING DEVICE

    MDR report key: 2192369 · Received August 4, 2011

    Report

    Report Number
    2939301-2011-06905
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    July 14, 2011
    Report Date
    July 14, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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

    DEVICE EVALUATION: THE LAY USER/PATIENT'S LANCING DEVICE HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE LANCING DEVICE INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE LANCING DEVICE CASED WAS FOUND TO BE CRACKED/BROKEN. 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) 2011, THE LAY-USER/PATIENT'S MOTHER CONTACTED LIFESCAN (LFS) TO REPORT A BROKEN CAP ISSUE WHEN HER SON ATTEMPTED TO OBTAIN A BLOOD SAMPLE USING HIS ONE TOUCH MINI LANCING DEVICE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT'S MOTHER REPORTED THAT THE ALLEGED ISSUE WITH THE SUBJECT LANCING DEVICE BEGAN ON (B)(6) 2011, AT 8 PM. SHE STATED THAT HER SON MANAGES HIS DIABETES WITH COMBINATION OF MEDICATIONS, INCLUDING METFORMIN. IT IS UNCLEAR IF THE PATIENT MADE ANY CHANGES TO HIS USUAL DIABETES TREATMENT DUE TO THE ALLEGED PRODUCT ISSUE. THE PATIENT'S MOTHER CLAIMED THAT 6 HOURS AFTER THE PRODUCT ISSUE STARTED, HE FELT DIZZY AND SHAKY, WHICH WAS ASSOCIATED TO LOW BLOOD GLUCOSE. IN RESPONSE TO HIS SYMPTOMS, ON (B)(6) 2011 AT 3 PM, HE HAD MORE FOOD AND DRINK TO HELP RELIEVE THE SYMPTOMS. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE PATIENT WAS USING THE CORRECT LFS CAP AND THAT THE PATIENT DENIED ANY MISUSE TO THE PRODUCT. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT'S MOTHER CLAIMS THAT HE WAS UNABLE TO TEST HIS BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA, WHICH REQUIRED INTERVENTION AFTER THE REPORTED ISSUE BEGAN.

    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 20 YR Life Threatening| R