BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRASOFT LANCING DEVICE

    MDR report key: 1060288 · Received June 10, 2008

    Report

    Report Number
    2939301-2008-01050
    Event Type
    Injury
    Date Received
    June 10, 2008
    Date of Event
    January 1, 2008
    Report Date
    May 29, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    FMK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT LFS PRODUCT FOR EVALUATION, BUT HAS NOT YET RECEIVED THEM. IF THE STRIPS ARE RETURNED, LIFESCAN WILL EVALUATE THEM AND, IF THE LFS PRODUCT DO 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 THREADS ON THE ONETOUCH ULTRA SOFT LANCING DEVICE ARE DAMAGED/STRIPPED. ON JUNE 9, 2008, THIS MEDICAL AFFAIRS SPECIALIST CONTACTED THE PATIENT TO OBTAIN MORE INFORMATION IN REGARDS TO INITIAL CALL. HOWEVER, THE PATIENT REFUSED TO PROVIDE ANY MORE INFORMATION. AFTER THE REPORTED ISSUE (THREADS DAMAGED/STRIPPED) BEGAN IN EARLY 2008, THE PATIENT HAD SYMPTOMS DESCRIBED AS "HEADACHE, SWEATING, LETHARGY, IRRITABILITY, AND VERTIGO." AS A RESULT OF THE REPORTED ISSUE, THE PATIENT DECREASED HIS INSULIN. THE PATIENT DID NOT RECEIVE ANY MEDICAL INTERVENTION BECAUSE OF THE REPORTED ISSUE. IT WOULD HAVE BEEN HELPFUL TO KNOW THE PATIENT'S DIABETES MEDICATION REGIMEN, WAS THE PATIENT STILL TESTING 4 TIMES PER DAY AFTER THE LFS LANCING DEVICE DID NOT WORK, HOW HE TREATED HIS REPORTED SYMPTOMS, IF HIS DIABETES MEDICATION REGIMEN CHANGED AFTER THE REPORTED ISSUE BEGAN IN THE SAME MONTH, AND THE EVENT LEADING UP TO THE ONSET OF THE PATIENT'S SYMPTOMS SUCH AS LFS METER READINGS, FOOD INTAKE, DIABETES MEDICATION INTAKE, AND PHYSICAL ACTIVITIES. DURING TROUBLESHOOTING, THE REPORTED ISSUE WAS NOT RESOLVED. THERE WAS NO INDICATION THAT THERE WAS ANY PRODUCT MISUSE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMED HE HAD SYMPTOMS THAT CAN BE SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ONSET OF THE REPORTED ISSUE (THREADS DAMAGED/STRIPPED). REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Life Threatening