BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 2180057 · Received July 27, 2011

    Report

    Report Number
    2954323-2011-03985
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    July 7, 2011
    Report Date
    September 22, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER WAS RETURNED AND INVESTIGATED. THE METER'S POWER CONSUMPTION WAS WITHIN SPECIFICATION. FAST DRAINING BATTERY WAS NOT OBSERVED. NO NEW ISSUES 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 THE BATTERY IS FAST DRAINING IN HER FREESTYLE FREEDOM LITE METER AND AS A RESULT OF BEING UNABLE TO OBTAIN ANY READINGS, SHE PASSED OUT. THE CUSTOMER REPORTEDLY SELF-PRESENTED TO A HEALTH CARE FACILITY WHERE SHE WAS TOLD "SHE HAD A FAINTING SPELL." NEITHER DIABETES-RELATED DIAGNOSIS NOR TREATMENT WAS PROVIDED. NO SELF-TREATMENT 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 1072417

    Patients

    Seq Age Sex Outcome Treatment
    1 Other