BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRASOFT LANCING DEVICE

    MDR report key: 1173431 · Received September 23, 2008

    Report

    Report Number
    2939301-2008-02358
    Event Type
    Injury
    Date Received
    September 23, 2008
    Report Date
    September 13, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    FMK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND STRIPS FOR EVAL, BUT HAS NOT YET RECEIVED THEM. IF EITHER THE METER OR STRIPS ARE RETURNED, LIFESCAN WILL EVALUATE IT/THEM AND, IF EITHER THE METER OR STRIPS DO NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE LAY USER/PT'S DAUGHTER CONTACTED LIFESCAN IN 2008 AND ALLEGED THAT THE PT HAD AN ISSUE WITH HER ONE TOUCH ULTRASOFT LANCING DEVICE. THE MEDICAL AFFAIRS SPECIALIST WAS UNABLE TO REACH THE DAUGHTER/PT AFTER SEVERAL ATTEMPTS VIA PHONE. A LETTER WAS SENT TO THE ADDRESS PROVIDED. THE DAUGHTER REPORTED THAT THE "SPRING" ON THE LANCING DEVICE IS BROKEN AND THAT THE ALLEGED ISSUE FIRST OCCURRED ABOUT 3 MONTHS AGO. SHE ALSO MENTIONED THE PT DEVELOPED "LOW" SYMPTOMS AND SHE DID NOT KNOW WHAT WAS GOING ON AT THE TIME. THE PT WAS REPORTEDLY "DISCOMBOBULATED", DISORIENTED, WEAK, SWEATY, AND COLD SOMETIME AFTER THE REPORTED ISSUE. A COUPLE OF WEEKS PRIOR TO HER CALL TO LIFESCAN, SHE TREATED SELF WITH FOOD/BEVERAGE. THE PT WAS NOT TESTED ON ANY OTHER DEVICE. AT THE TIME OF TROUBLESHOOTING, IT WAS VERIFIED THAT THIS WAS NOT A NEW PRODUCT. BASED ON THE INFO PROVIDED, THERE WAS NO MISUSE OF THE PRODUCT. THE PT WAS USING A REGULAR CAP WITH THE DEVICE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE DAUGHTER CLAIMED THAT THE PT EXPERIENCED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AND TREATED HERSELF TWO WEEKS PRIOR TO THE CALL TO LFS. THE REPORTED ISSUE ALLEGEDLY BEGAN 3 MONTHS AGO. THE ALLEGED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. IT IS NOT CLEAR IF THE PT WAS ABLE TO TEST HER BLOOD GLUCOSE, DUE TO THE ALLEGED ISSUE. REPLACEMENT PRODUCTS WERE SENT TO THE LAY USER/PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRASOFT LANCING DEVICE GLUCOSE MONITORING SYS/KIT FMK LIFESCAN, INC. NA NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Life Threatening