BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 2140050 · Received June 25, 2011

    Report

    Report Number
    2954323-2011-03670
    Event Type
    Injury
    Date Received
    June 25, 2011
    Date of Event
    June 1, 2011
    Report Date
    August 2, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METER'S POWER CONSUMPTION WAS INVESTIGATED AND FOUND TO BE WITHIN SPECIFICATION. FAST DRAINING BATTERY ISSUE WAS NOT OBSERVED. NO ADDITIONAL ISSUES WERE OBSERVED. THE COMPLAINT IS NOT CONFIRMED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CUSTOMER REPORTED HIS FREESTYLE FREEDOM LITE BLOOD GLUCOSE METER HAD A FAST-DRAINING BATTERY AND NOTED IT STOPPED WORKING ON (B)(6), 2011. HE FURTHER REPORTED THAT ON (B)(6), 2011 DUE TO THIS ISSUE HE COULD NOT TEST AND EXPERIENCED POLYDIPSIA, POLYURIA, "PAIN IN KIDNEY AREA", BODY ACHES AND SUBSEQUENTLY A SEIZURE. NO THIRD-PARTY EMERGENT MEDICAL INTERVENTION WAS REPORTED. CUSTOMER SELF-TREATED BY TAKING NEURONTIN (GABAPENTIN), IBUPROFEN AND WATER. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FREEDOM LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1025726

    Patients

    Seq Age Sex Outcome Treatment
    1 Other