BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 2140075 · Received June 25, 2011

    Report

    Report Number
    2954323-2011-03673
    Event Type
    Injury
    Date Received
    June 25, 2011
    Date of Event
    June 3, 2011
    Report Date
    October 15, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. THE PRODUCT HAS BEEN REQUESTED BACK FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. TWO ATTEMPTS WERE MADE TO FOLLOW-UP WITH THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION WITHOUT SUCCESS.

    Additional Manufacturer Narrative · 1

    AS PRODUCT WAS NOT RETURNED, A DHR OF THE METER WAS REQUESTED. THE DEVICE HISTORY REVIEW FOR METER SN (B)(4) INDICATED THE DEVICE WAS PERFORMING WITHIN ITS PERFORMANCE CLAIMS AND MET THE MANUFACTURER'S QUALITY SPECIFICATIONS PRIOR TO ITS RELEASE. NO RETAIN TESTING WAS PERFORMED DUE TO STRIP LOT NUMBER 0830227 BEING EXPIRED. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    AN REPRESENTATIVE FROM A MEDICAL CARE CLINIC REPORTED A CUSTOMER RECEIVED HIGHER THAN FEELS READINGS OF 275 MG/DL AND/OR 110 MG/DL ON A FREESTYLE LITE METER ON (B)(6), 2011. THE REPRESENTATIVE REPORTED THAT THE CUSTOMER EXPERIENCED SYMPTOMS OF LIGHTHEADEDNESS FOLLOWED BY A LOSS OF CONSCIOUSNESS. THE REPRESENTATIVE REPORTED NO INJURY WAS SUSTAINED, AND THE CUSTOMER WAS NOT TRANSPORTED TO A HEALTH CARE FACILITY FOR EMERGENCY TREATMENT. HOWEVER, THE REPRESENTATIVE WAS UNABLE TO PROVIDE INFORMATION REGARDING DIAGNOSIS OR TREATMENT FOR THE EVENT. 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 0830227

    Patients

    Seq Age Sex Outcome Treatment
    1 Other