BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRASOFT LACING DEVICE

    MDR report key: 1181640 · Received September 29, 2008

    Report

    Report Number
    2939301-2008-02439
    Event Type
    Injury
    Date Received
    September 29, 2008
    Report Date
    September 15, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    FMK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT LANCING DEVICE FOR EVALUATION, BUT HAS NOT YET REC'D IT. IF THE LANCING DEVICE IS RETURNED. LIFESCAN WILL EVALUATE IT AND, IF THE LANCING DEVICE DOES NOT PASS INSPECTION. LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IN 2008, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT THE CAP OF A ONETOUCH ULTRASOFT LANCING DEVICE WAS LOOSE/FALLING OFF. THE MEDICAL AFFAIRS SPECIALIST (MAS) WAS UNABLE TO CONTACT THE PT BY TELEPHONE ON TWO SEPARATE DAYS. THE PT INDICATED THAT THE ALLEGED METER ISSUE STARTED ON AN UNSPECIFIED DATE/TIME A COUPLE OF WEEKS PRIOR TO CONTACTING LFS ON THE SAME DAY. THE PT DID NOT TAKE ANY ACTIONS RELATED TO DIABETES TREATMENT AS A RESULT OF THE ALLEGED METER ISSUE. ON AN UNKNOWN DATE/TIME AFTER THE ALLEGED METER ISSUE BEGAN, THE PT CLAIMED THAT HE DEVELOPED SYMPTOMS OF FATIGUE AND BLURRY VISION. THE PT DENIED RECEIVING MEDICAL INTERVENTION FROM A HEALTH CARE PROVIDER AND WAS NOT TESTED ON ANOTHER DEVICE DURING THE TIME OF CONCERN. IT WOULD HAVE BEEN HELPFUL TO KNOW THE FOLLOWING INFO: THE PATIENT'S TESTING FREQUENCY, HIS MEDICATION AND DIABETES MANAGEMENT REGIMENS, WHAT ACTIONS THE PT TOOK IN RESPONSE TO THE LANCING DEVICE ISSUE, AND WHAT ACTIONS THE PT TOOK BEFORE AND AFTER THE SYMPTOMS DEVELOPED. IN ADDITION, IT WOULD HAVE BEEN HELPFUL TO KNOW IF THE PT ATTRIBUTED THE SYMPTOMS TO HIGH OR LOW BLOOD GLUCOSE, WHAT DATE/ TIME THE SYMPTOMS STARTED, AND IF THE PT WAS STILL ABLE TO TEST HIS BLOOD GLUCOSE DURING THE TIME OF CONCERN. THE LANCING DEVICE WAS REPLACED. BASED ON THE INFO PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PT CLAIMED THAT HE DEVELOPED SYMPTOMS THAT CAN BE ASSOCIATED WITH HYPERGLYCEMIA AFTER THE ALLEGED LANCING DEVICE ISSUE BEGAN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Life Threatening