BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 1850639 · Received October 1, 2010

    Report

    Report Number
    2954323-2010-01361
    Event Type
    Injury
    Date Received
    October 1, 2010
    Date of Event
    September 9, 2010
    Report Date
    October 31, 2010
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER'S PRODUCT WAS RETURNED AND INVESTIGATED. THE COMPLAINT WAS NOT CONFIRMED AND NO NEW ISSUES WERE OBSERVED. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING. THIS IS A FINAL REPORT.

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING A READING (NOT PROVIDED) ON HER FREESTYLE FREEDOM LITE BLOOD GLUCOSE METER THAT WAS HIGHER THAN SHE FELT. SHE FURTHER REPORTED EXPERIENCING TREMULOUSNESS, NAUSEA, VOMITING AND SUBSEQUENTLY, A LOSS OF CONSCIOUSNESS. PARAMEDICS WERE CALLED, BUT CUSTOMER WAS UNABLE TO REPORT WHAT TREATMENT WAS PROVIDED AND THEN REFUSED TO ANSWER ANY FURTHER QUESTIONS. CUSTOMER SERVICE ATTEMPTED, WITHOUT SUCCESS, TO GATHER ADDITIONAL INFORMATION FROM THE CUSTOMER. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    THE SURGEON REPORTED THE INTRAOCULAR LENS(IOL) WAS EXPLANTED WITHOUT COMPLICATION 2 MONTHS AFTER THE INITIAL IMPLANT. THE CAUSE OF THE IOL EXPLANT WAS POSITIVE DYSPHOTOPSIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FREEDOM LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 0909031

    Patients

    Seq Age Sex Outcome Treatment
    1 Other