BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRASOFT LANCING DEVICE

    MDR report key: 1181633 · Received September 29, 2008

    Report

    Report Number
    2939301-2008-02445
    Event Type
    Injury
    Date Received
    September 29, 2008
    Date of Event
    July 23, 2008
    Report Date
    September 22, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    FMK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT LFS PRODUCT FOR EVALUATION, BUT HAS NOT YET REC'D IT. IF THE PRODUCT IS RETURNED, LIFESCAN WILL EVALUATE THEM AND, IF THE PRODUCT 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 CONTACT LIFESCAN (LFS) ALLEGING THAT THE ONETOUCH ULTRASOFT LANCING DEVICE HAS A LOOSE CAP AND AT TIMES FALLS OFF. THE PT CLAIMED THAT THE LOOSE CAP ISSUE FIRST OCCURRED ON THE EVENT DATE. SOMETIME AFTER THE REPORTED ISSUE BEGAN, THE PT WAS TESTED WITH A BACKUP METER, REPORTEDLY OBTAINING A BLOOD GLUCOSE READING OF "60 MG/DL" AND HAD SYMPTOMS DESCRIBED AS "LIGHTHEADED, NERVOUS, AND SHAKY." THE PT DID NOT TAKE ANY ACTION IN REGARDS TO DIABETES TREATMENT AND DID NOT RECEIVE ANY MEDICAL INTERVENTION BECAUSE OF THE REPORTED ISSUE. IT WOULD HAVE BEEN HELPFUL TO KNOW THE PT'S DIABETES MEDICATION REGIMEN AND TESTING FREQUENCY, AND THE EVENTS LEADING UP TO THE PT'S MEDICAL INTERVENTION SUCH AS BLOOD GLUCOSE READINGS, DIABETES MEDICATION INTAKE, FOOD INTAKE, AND PHYSICAL ACTIVITIES. DURING TROUBLESHOOTING, THE REPORTED ISSUE WAS NOT RESOLVED. THERE WAS NO INDICATION OF PRODUCT MISUSED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT CLAIMED THAT SHE HAD SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AFTER THE REPORTED ISSUE BEGAN. REPLACEMENT PRODUCTS WERE SENT TO THE PT.

    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 46 YR Life Threatening