BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH LANCING DEVICE

    MDR report key: 1890443 · Received November 3, 2010

    Report

    Report Number
    2939301-2010-09672
    Event Type
    Injury
    Date Received
    November 3, 2010
    Report Date
    October 20, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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

    THE LAY USER / PATIENT CONTACTED LFS ON (B)(6), 2010 ALLEGING THAT HER LANCET HOLDER WAS DAMAGED ON HER LANDING DEVICE . A MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNSUCCESSFUL IN GETTING A HOLD OF THE PATIENT AND SENT A LETTER TO OBTAIN FURTHER CLINICAL INFORMATION: THE PATIENT MENTIONED THAT THE ALLEGED ISSUE BEGAN SOMETIME A YEAR AGO. SHE DOES NOT RECALL THE EXACT DATE. ON (B)(6), 2010, THE PATIENT DEVELOPED SYMPTOMS OF BLURRED VISION. IT IS UNKNOWN WHETHER THE PATIENT ATTEMPTED TO TEST HER BLOOD GLUCOSE DURING THE ALLEGED ISSUE WITH JUST THE LANCET. THE PATIENT DOES NOT TAKE ANY MEDICATION. THE PATIENT DID NOT SELF-TREAT OR SEEK ANY MEDICAL ATTENTION DUE TO THE ALLEGED ISSUE. BASED ON THE INITIAL CALL THERE WAS NO MISUSE OF THE LANCING DEVICE. THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE REPORTER ALLEGED THAT DUE TO THE LANCET HOLDER BEING DAMAGED, SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE AND LATER DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY.

    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 54 YR Life Threatening