BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRASOFT LANCING DEVICE

    MDR report key: 1261256 · Received December 8, 2008

    Report

    Report Number
    2939301-2008-03506
    Event Type
    Injury
    Date Received
    December 8, 2008
    Date of Event
    June 30, 1905
    Report Date
    November 13, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    FMK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    LAY USER/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

    IN 2008, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT THE CASING OF A ONE TOUCH ULTRASOFT LANCING DEVICE WAS CRACKED/BROKEN. THE PATIENT INDICATED THAT THE ALLEGED LANCING DEVICE ISSUE STARTED ON AN UNSPECIFIED DATE/TIME TWO MONTHS PRIOR TO CONTACTING LFS THE SAME DAY. AS A RESULT OF THE ALLEGED ISSUE, THE PATIENT REPORTEDLY CONSUMED MORE FOOD/DRINK(S). ON AN UNKNOWN DATE/TIME AFTER THE ALLEGED LANCING DEVICE ISSUE BEGAN, THE PATIENT CLAIMED THAT HE DEVELOPED SYMPTOMS OF WEAKNESS, DIZZINESS, HUNGER, AND THIRST. THE PATIENT DENIED RECEIVING TREATMENT AS A RESULT OF THE REPORTED ISSUE. IT WOULD HAVE BEEN HELPFUL TO KNOW THE FOLLOWING INFORMATION: THE PATIENT'S TESTING FREQUENCY, HIS MEDICATION AND DIABETES MANAGEMENT REGIMENS, WHAT APPROXIMATE DATE/TIME THE SYMPTOMS DEVELOPED, WHAT ACTIONS THE PATIENT TOOK BEFORE AND AFTER THE SYMPTOMS DEVELOPED. IN ADDITION, IT WOULD HAVE BEEN HELPFUL TO KNOW IF THE PATIENT WAS STILL ABLE TO TEST HIS BLOOD GLUCOSE DURING THE TIME OF CONCERN. THE LANCING DEVICE WAS REPLACED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT HE DEVELOPED SYMPTOMS THAT CAN BE SUGGESTIVE OF HYPERGLYCEMIA AFTER THE ALLEGED LANCING DEVICE ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRASOFT LANCING DEVICE GLUCOSE MONITORING SYS/KIT FMK LIFESCAN, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Life Threatening