BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 2221951 · Received August 24, 2011

    Report

    Report Number
    2954323-2011-04289
    Event Type
    Injury
    Date Received
    August 24, 2011
    Date of Event
    August 9, 2011
    Report Date
    August 24, 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 WHEN ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    A CUSTOMER'S WIFE REPORTED THE CUSTOMER RECEIVED AN ERROR 4 MESSAGE UPON STRIP INSERTION USING HIS FREESTYLE FREEDOM LITE GLUCOSE METER. THE CALLER REPORTED THAT ON (B)(6) 2011 "IN THE AFTERNOON AND INTO THE NIGHT" THE CUSTOMER WAS UNABLE TO TEST DUE TO THE ERROR 4 MESSAGE. AS A RESULT, THE CUSTOMER EXPERIENCED SYMPTOMS DESCRIBED AS "LETHARGIC, OUT OF IT, JUST DIDN'T FEEL WELL, EXCESSIVE URINATION, EXTRA THIRSTY." THE CUSTOMER SELF-PRESENTED TO A HEALTH CARE FACILITY AND WAS DIAGNOSED WITH HYPERGLYCEMIA AND "A MUSCLE SPASM IN HIS BACK". THE CUSTOMER WAS TREATED WITH INSULIN (DOSAGE/TYPE NOT SPECIFIED), WHICH WAS A CHANGE TO HIS NORMAL MEDICATIONS. NO SELF-TREATMENT WAS REPORTED. THERE IS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FREEDOM LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 0935102

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention