BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 3844193 · Received June 2, 2014

    Report

    Report Number
    2954323-2014-00616
    Event Type
    Injury
    Date Received
    June 2, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 7, 2014
    Product Code
    NBW
    PMA / PMN Number
    K092602
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCTS HAVE 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

    AS PRODUCT WAS NOT RETURNED AND NO TEST STRIP LOT WAS REPORTED WITH THIS COMPLAINT, A DEVICE HISTORY REVIEW (DHR) OF THE METER WAS REQUESTED. THE DHR FOR METER SERIAL NUMBER (B)(4) INDICATED THE DEVICE WAS PERFORMING WITHIN ITS PERFORMANCE CLAIMS AND MET THE MANUFACTURER'S QUALITY SPECIFICATIONS PRIOR TO ITS RELEASE. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT ON (B)(6) 2014 HE RECEIVED A NEW ADC BLOOD GLUCOSE METER KIT FROM ADC WHICH WAS MISSING THE BATTERY AND LANCING DEVICE/LANCET. HE FURTHER REPORTED THE PACKAGE APPEARED TO HAVE BEEN TAMPERED WITH AND NOTED THE METER'S SCREEN WAS SCRATCHED. CUSTOMER BEGAN TO EXPERIENCE "SWEATING AND WAS SICK TO (HIS) STOMACH" BUT COULD NOT TEST, SO HE SELF-PRESENTED TO A LOCAL HEALTHCARE FACILITY TO HAVE HIS GLUCOSE CHECKED. CUSTOMER WAS DIAGNOSED WITH HYPERGLYCEMIA (NO HOSPITAL READING WAS PROVIDED) AND TREATED WITH METFORMIN AND 5 UNITS OF INSULIN. CUSTOMER WAS ALSO GIVEN VITAMIN B12 AND FOLIC ACID, WHICH WERE REPORTEDLY NEWLY PRESCRIBED. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322429 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM NBW

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention