BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 1982949 · Received February 9, 2011

    Report

    Report Number
    2954323-2011-01557
    Event Type
    Injury
    Date Received
    February 9, 2011
    Date of Event
    January 14, 2011
    Report Date
    April 7, 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)(4)) 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

    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.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED RECEIVING ERRATIC READINGS OF 271 MG/DL AT 11:30 A.M. AND 74 MG/DL AT 12:15 P.M., HOWEVER THEY WERE NOT OBTAINED WITHIN 10 MINUTES, HENCE ARE INVALID FOR COMPARISON. THE CUSTOMER FURTHER REPORTED LOSING CONSCIOUSNESS AND SELF-TREATING WITH HONEY TO COUNTERACT THE EVENT. NO THIRD-PARTY MEDICAL INTERVENTION WAS REPORTED. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FREEDOM LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1080112

    Patients

    Seq Age Sex Outcome Treatment
    1 Other