BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM

    MDR report key: 2112080 · Received June 2, 2011

    Report

    Report Number
    2954323-2011-03473
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    April 24, 2011
    Report Date
    August 16, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS TESTED AND AN ERROR MESSAGE RELATED TO SOFTWARE CORRUPTION WAS FOUND. THE USER MANUAL PROVIDES RECOMMENDED INSTRUCTIONS FOR THE USER TO TROUBLE SHOOT INSTANCES IN WHICH THE METER DISPLAYS AN ERROR MESSAGE. IN ADDITION, THE MANUAL STATES TO CONTACT CUSTOMER SERVICE SHOULD ADDITIONAL ASSISTANCE BE NEEDED. THIS IS A FINAL REPORT.

    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 AN ERROR-4 MESSAGE ON HIS FREESTYLE FREEDOM BLOOD GLUCOSE METER. AS A RESULT OF THE ERROR MESSAGE, THE CUSTOMER WAS UNABLE TO TEST. ON (B)(6) 2011 AT 3:00PM THE CUSTOMER EXPERIENCED SYMPTOMS OF FATIGUE AND DIAPHORESIS FOLLOWED BY A LOSS OF CONSCIOUSNESS. PARAMEDICS WERE CALLED; THE CUSTOMER WAS TREATED WITH GLUCOSE ON THE SCENE AND TRANSPORTED TO A HOSPITAL WHERE HE WAS DIAGNOSED WITH HYPOGLYCEMIA. TREATMENT INCLUDED INTRAVENOUS, ORAL AND INJECTABLE MEDICATION(S). 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 FREEDOM BLOOD GLUCOSE MONITORING SYSTEM NBW 1020905

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R