BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 2736051 · Received September 7, 2012

    Report

    Report Number
    2954323-2012-06552
    Event Type
    Injury
    Date Received
    September 7, 2012
    Date of Event
    August 16, 2012
    Report Date
    August 16, 2012
    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 AVAILABLE. THE DATE OF THE EVENT IS UNKNOWN. IT SHOULD BE NOTED THAT THE CUSTOMER WAS USING EXPIRED TEST STRIPS (LOT # 1070205, EXP. JUL/12). ALL PERTINENT DATA AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THEIR ADC GLUCOSE METER SHUTS OFF AFTER A SAMPLE IS APPLIED TO THE TEST STRIP. THE CUSTOMER REPORTED EXPERIENCING AN UNSPECIFIED INJURY RELATED TO THIS ISSUE, BUT REFUSED TO TROUBLESHOOT OR COMPLETE A MEDICAL SURVEY AND DISCONNECTED THE PHONE CALL. AN ATTEMPT WAS MADE TO CONTACT THE CUSTOMER, BUT HE DISCONNECTED THE CALL PRIOR TO PROVIDING ANY ADDITIONAL INFORMATION. THERE IS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FREEDOM LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1070205

    Patients

    Seq Age Sex Outcome Treatment
    1 Other