BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 1894413 · Received November 9, 2010

    Report

    Report Number
    2954323-2010-01536
    Event Type
    Injury
    Date Received
    November 9, 2010
    Date of Event
    October 20, 2010
    Report Date
    December 29, 2010
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RETURNED METER (B)(4) AND STRIP LOT NUMBER 1068913. THE COMPLAINT WAS NOT CONFIRMED AND ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION DURING CONTROL SOLUTION TESTING.

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. THE CUSTOMER'S PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE TEST DID NOT START WHEN SHE INSERTED A TEST STRIP INTO HER FREESTYLE LITE BLOOD GLUCOSE METER. SHE NOTED THE TEST STRIP DID NOT APPEAR TO BE WICKING THE BLOOD. SHE FURTHER REPORTED HAVING TO USE MULTIPLE TEST STRIPS, BUT THE METER NEVER GAVE HER A READING AND THIS RESULTED IN HER SUSTAINING AN UNSPECIFIED INJURY. CUSTOMER DECLINED TO PROVIDE A DATE WHEN THE ISSUE OCCURRED OR WHEN THE INJURY WAS SUSTAINED. CUSTOMER ALSO REFUSED TO PROVIDE ANY INFORMATION REGARDING HER INJURY AND DECLINED TO PROVIDE ANY CONTACT INFORMATION. IT IS UNKNOWN IF THE CUSTOMER RECEIVED THIRD-PARTY MEDICAL INTERVENTION OR IF SHE ATTEMPTED SELF-TREATMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1068913

    Patients

    Seq Age Sex Outcome Treatment
    1 Other