BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 1818704 · Received August 27, 2010

    Report

    Report Number
    2954323-2010-01179
    Event Type
    Injury
    Date Received
    August 27, 2010
    Date of Event
    June 23, 2010
    Report Date
    August 27, 2010
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S PRODUCT HAS BEEN REQUESTED BACK FOR INVESTIGATION AND A SUPPLEMENTAL REPORT WILL BE SENT ONCE PRODUCT HAS BEEN RECEIVED AND THE INVESTIGATION RESULTS ARE AVAILABLE.

    Description of Event or Problem · 1

    AN ADC CUSTOMER STATED THAT BACK IN MAY (SPECIFIC DATE UNKNOWN) HER FS FREEDOM LITE METER WOULD NOT TURN ON WITH STRIP INSERTION WITH TEST STRIP LOT (0924320) AND RECEIVED AN ERROR 4 MESSAGE WHILE ATTEMPTING TO INSERT TEST STRIP LOT (1013501). CUSTOMER DID NOT REPORT HAVING AN ALTERNATE MEANS OF TESTING AND STATED ON (B)(4), 2010, WHILE AT HOME, SHE EXPERIENCED BOTH SEIZURE ACTIVITY AND A LOSS OF CONSCIOUSNESS. PARAMEDICS WERE CALLED AND CUSTOMER WAS TRANSPORTED TO A HEALTH CARE FACILITY. CUSTOMER WAS DIAGNOSED WITH HYPERGLYCEMIA HOWEVER, SHE COULD NOT RECALL THE SPECIFIC TREATMENT OR INTERVENTION RENDERED TO HER AT THE HOSPITAL. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FREEDOM LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 0924320

    Patients

    Seq Age Sex Outcome Treatment
    1 Other