BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 3062149 · Received April 16, 2013

    Report

    Report Number
    2954323-2013-00230
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    March 20, 2013
    Report Date
    March 24, 2013
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE METER WAS RETURNED AND INVESTIGATED. THE COMPLAINT WAS NOT CONFIRMED AND NO NEW ISSUES WERE OBSERVED. METER POWERED ON WITH BUTTON DEPRESSION AND TEST STRIP INSERTION. BLANK SCREEN WAS NOT OBSERVED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED HE WAS UNABLE TO TEST DUE TO HIS ADC BLOOD GLUCOSE METER NOT POWERING ON WITH BUTTON PRESS OR TEST STRIP INSERTION. CUSTOMER FURTHER REPORTED NEUROPATHY IN HIS FEET, STATING HE HAD EXPERIENCED A "BURNING" AND "SHARP NEEDLE" SENSATION FOR APPROXIMATELY FOUR DAYS. CUSTOMER ADDITIONALLY REPORTED EXPERIENCING A LOSS OF CONSCIOUSNESS AND REPORTEDLY SELF-TREATED WITH BOTH INSULIN AND METFORMIN. THERE WAS NO REPORT OF THIRD-PARTY MEDICAL INTERVENTION. NO DEATH OR PERMANENT IMPAIRMENT IS ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162244 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1269206

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other