BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM

    MDR report key: 1912103 · Received December 1, 2010

    Report

    Report Number
    2954323-2010-01627
    Event Type
    Injury
    Date Received
    December 1, 2010
    Date of Event
    November 12, 2010
    Report Date
    December 1, 2010
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. THE CUSTOMER'S PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. IT SHOULD BE NOTED: A FOLLOW-UP CALL WAS MADE TO THE CUSTOMER TO CLARIFY THE DIAGNOSIS AND TREATMENT RECEIVED. CUSTOMER REITERATED THE DIAGNOSIS OF HYPOGLYCEMIA AND TREATMENT WITH INSULIN.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING AN UNKNOWN ERROR MESSAGE ON THE DISPLAY OF HIS FREESTYLE FREEDOM BLOOD GLUCOSE METER, THE FIRST TIME HE ATTEMPTED TO USE IT. THE ERROR MESSAGE WAS DISPLAYED ON (B)(6) 2010. CUSTOMER FURTHER REPORTED EXPERIENCING VERTIGO IN THE MORNING. CUSTOMER SELF-PRESENTED TO HIS HEALTHCARE PROVIDER, WAS DIAGNOSED WITH HYPOGLYCEMIA AND REPORTEDLY TREATED WITH 100 UNITS OF NOVOLIN-N INSULIN. CUSTOMER DENIED SELF-TREATING. 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 FREEDOM BLOOD GLUCOSE MONITORING SYSTEM NBW 1020712

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention