BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 2122370 · Received June 13, 2011

    Report

    Report Number
    2954323-2011-03547
    Event Type
    Injury
    Date Received
    June 13, 2011
    Date of Event
    May 21, 2011
    Report Date
    July 22, 2011
    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 AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. ADDITIONALLY: THE DATE OF MANUFACTURE OF THE DEVICE IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS NOT CONFIRMED AND NO NEW ISSUES WERE OBSERVED. LANCING DEVICE WAS MOUNTED ONTO SIMULATED SKIN AND FIRED. THE LANCING DEVICE DID ARM/FIRE CORRECTLY AND SPRING BACK WHEN COCKED. DID NOT OBSERVE ARMING/FIRING ISSUE WITH LANCING DEVICE. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE LANCING DEVICE SHE USES WITH HER FREESTYLE LITE BLOOD GLUCOSE METER "IS NOT SPRINGING BACK WHEN COCKED" WHICH PREVENTED HER FROM TESTING. SHE FURTHER REPORTED SUBSEQUENTLY EXPERIENCING LIGHTHEADEDNESS WHICH RESULTED IN A LOSS OF CONSCIOUSNESS WHILE SHE WAS AT CHURCH. NO THIRD-PARTY EMERGENT MEDICAL INTERVENTION WAS REPORTED. CUSTOMER SELF-TREATED BY "EATING A PLATE OF FOOD" UPON ARRIVING HOME AND THEN TAKING A NAP, NOTING SHE FELT BETTER WHEN SHE WOKE UP. 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 LITE BLOOD GLUCOSE MONITORING SYSTEM NBW

    Patients

    Seq Age Sex Outcome Treatment
    1 Other