BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 2071239 · Received April 27, 2011

    Report

    Report Number
    2954323-2011-03084
    Event Type
    Injury
    Date Received
    April 27, 2011
    Date of Event
    April 1, 2011
    Report Date
    May 25, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED.

    Additional Manufacturer Narrative · 1

    THE RETURNED METER (B)(4) WAS TESTED WITH RETAINED TEST STRIPS. CONTROL SOLUTION TESTING WAS PERFORMED. ALL RESULTS WERE WITHIN RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED. NO NEW ISSUES WERE OBSERVED. THE COMPLAINT IS NOT CONFIRMED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED HE RECEIVED AN ERROR-3 DISPLAY MESSAGE ON HIS FREESTYLE FREEDOM LITE BLOOD GLUCOSE METER UPON SAMPLE APPLICATION, AND AS A RESULT HE EXPERIENCED LOSS OF CONSCIOUSNESS ON (B)(6) 2011 AT 10:00 PM. THE PARAMEDICS WERE CALLED AND THEY REPORTEDLY ADMINISTERED AN INTRAVENOUS GLUCOSE SOLUTION, AND SUBSEQUENTLY TRANSPORTED HIM TO A HEALTH CARE FACILITY WHERE HE WAS DIAGNOSED WITH HYPOGLYCEMIA, BUT DID NOT REMEMBER THE TREATMENT RENDERED. 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 1001320

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R