BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 1903842 · Received November 20, 2010

    Report

    Report Number
    2954323-2010-01582
    Event Type
    Injury
    Date Received
    November 20, 2010
    Date of Event
    October 30, 2010
    Report Date
    January 4, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S PRODUCT WAS RETURNED AND INVESTIGATED. A LOW BATTERY ICON WAS OBSERVED WITH THE RETURNED BATTERY THEREFORE A BRAND NEW BATTERY WAS USED FOR TESTING. THE COMPLAINT WAS NOT CONFIRMED. THIS IS A FINAL REPORT.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. DURING THE COURSE OF THE TROUBLESHOOTING SURVEY, THE CUSTOMER REPORTED SHE COULD SEE ON THE METER SCREEN A "BATTERIES" MESSAGE, OR A BATTERY ICON, OR A "REPLACE BATTERIES" MESSAGE. ADC CUSTOMER SERVICE EDUCATED THE CUSTOMER ABOUT BATTERY REPLACEMENT.

    Description of Event or Problem · 1

    SERVICE OF SUMMONS AND COMPLAINT WAS MANUFACTURER'S FIRST NOTICE OF THIS EVENT. PLAINTIFF'S COUNSEL CLAIMS IN THE COMPLAINT THAT THE PATIENT WAS INJURED REQUIRING MEDICAL TREATMENT TO LEFT KNEE. SHE ALLEGES THAT CRYOTHERAPY WAS APPLIED. THE COMPLAINT CONTAINS NO INFORMATION ABOUT THE THERAPY PROTOCOL PRESCRIBED BY PLAINTIFF'S DOCTOR (E.G., DURATION OF COLD THERAPY SESSIONS AND BREAKS IN BETWEEN SAME, TEMPERATURE SETTINGS) THE BARRIER PLACED BETWEEN THE DEVICE AND THE PATIENT'S SKIN, INSTRUCTIONS PROVIDED TO THE PATIENT ABOUT USE OF THE DEVICE OR WHETHER THERE WERE ANY CONTRAINDICATIONS FOR COLD THERAPY. PLAINTIFF CLAIMS SHE SUFFERED PERSONAL INJURIES RESULTING IN DISFIGUREMENT AND PHYSICAL IMPAIRMENT. THE COMPANY HAS BEEN UNABLE TO CONFIRM THE MANUFACTURER OF OR INSPECT THE DEVICE. BECAUSE THE MATTER IS IN LITIGATION, IT HAS BEEN TURNED OVER TO OUTSIDE COUNSEL FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED HER FREESTYLE LITE BLOOD GLUCOSE METER WOULD SHUT OFF DURING TESTING AFTER THE BLOOD WAS APPLIED TO THE TEST STRIP. DUE TO THE METER NOT WORKING, THE CUSTOMER REPORTED SHE EXPERIENCED DIZZINESS AND LOSS OF CONSCIOUSNESS. ALTHOUGH THE CUSTOMER REPORTEDLY STATED SHE "BROKE HER NOSE AND HURT HER FOOT AND KNEE", SHE ALSO REPORTED THAT NO PARAMEDICS AND NO FURTHER THIRD-PARTY MEDICAL INTERVENTION WAS REQUIRED. THE CUSTOMER REPORTED SHE TOOK HER REGULAR PRESCRIPTION MEDICATION (METFORMIN). THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1072908

    Patients

    Seq Age Sex Outcome Treatment
    1 Other