BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 2020813 · Received March 16, 2011

    Report

    Report Number
    2954323-2011-02253
    Event Type
    Injury
    Date Received
    March 16, 2011
    Date of Event
    February 20, 2011
    Report Date
    May 24, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REQUESTED PRODUCT WAS NOT RECEIVED FOR INVESTIGATION. RETAINED TEST STRIP SAMPLES FROM THE SAME LOT REPORTED BY THE CUSTOMER ((B)(6)) WERE TESTED WITH CONTROL SOLUTION INSTEAD. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED. THE COMPLAINT IS NOT CONFIRMED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. NOTE: REGARDING THE READINGS OF 207 MG/DL AND 265 MG/DL, RESULTS WERE PLOTTED ON A PARKES ERROR GRID AND FELL INTO THE "A" ZONE SHOWING THE DIFFERENCE IN VALUES WAS NOT CLINICALLY SIGNIFICANT. REGARDING THE READINGS OF 207 MG/DL AND 206 MG/DL, RESULTS WERE PLOTTED ON A PARKES ERROR GRID AND FELL INTO THE "A" ZONE SHOWING THE DIFFERENCE IN VALUES WAS NOT CLINICALLY SIGNIFICANT.

    Description of Event or Problem · 1

    THE CUSTOMER'S WIFE REPORTED THE CUSTOMER RECEIVED WITHIN TEN MINUTES THE READINGS OF 207 MG/DL AND 265 MG/DL ON HIS FREESTYLE FREEDOM LITE BLOOD GLUCOSE METER. THE FOLLOWING READINGS OF 206 MG/DL AND 207 MG/DL WERE ALSO REPORTED. HOWEVER, THE CUSTOMER'S WIFE WAS UNSURE WHICH READINGS WERE RELATED TO THE MEDICAL EVENT. AS RESULT THE CUSTOMER REPORTEDLY SELF-MEDICATED BASED ON READINGS AND THEN EXPERIENCED SYMPTOMS OF LIGHTHEADEDNESS, SWEATINESS AND LOSS OF CONSCIOUSNESS. NO THIRD-PARTY MEDICAL INTERVENTION WAS REQUIRED AND NO MEDICATIONS WERE REPORTEDLY TAKEN TO COUNTERACT THE EVENT. THERE WAS 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 1035214

    Patients

    Seq Age Sex Outcome Treatment
    1 Other