BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 2441595 · Received February 7, 2012

    Report

    Report Number
    2954323-2012-05822
    Event Type
    Injury
    Date Received
    February 7, 2012
    Date of Event
    January 8, 2012
    Report Date
    June 15, 2012
    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.

    Additional Manufacturer Narrative · 1

    REQUESTED PRODUCT WAS NOT RECEIVED FOR INVESTIGATION. RETAINED TEST STRIP SAMPLES FROM THE SAME LOT REPORTED BY THE CUSTOMER (1160258) WERE TESTED WITH CONTROL SOLUTION INSTEAD. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED. THE COMPLAINT IS NOT CONFIRMED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THEY RECEIVED A HIGHER THAN FEELS READING OF 117 MG/DL AT 12:44 PM ON (B)(6) 2012 ON THEIR ADC METER AND EXPERIENCED LIGHTHEADEDNESS WITH A SUBSEQUENT LOSS OF CONSCIOUSNESS. THE PARAMEDICS WERE CALLED, TREATED CUSTOMER WITH GLUCOSE INJECTION AND AN IV OF UNKNOWN TYPE AND TRANSPORTED TO A HOSPITAL WHERE HE WAS DIAGNOSED WITH HYPOGLYCEMIA AND CONGESTIVE HEART FAILURE. 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 LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1160258

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R