BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 1273084 · Received December 22, 2008

    Report

    Report Number
    2954323-2008-03086
    Event Type
    Injury
    Date Received
    December 22, 2008
    Date of Event
    November 27, 2008
    Report Date
    December 22, 2008
    Manufacturer
    ABBOTT DIABETES CARE INC., USA
    Product Code
    LFR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S PROD HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A F/U REPORT WILL BE SUBMITTED IF THE METER IS RETURNED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED SHE LOST CONSCIOUSNESS DUE TO READINGS SHE REC'D ON HER METER. THE CUSTOMER REPORTED OBTAINING THE FOLLOWING NON-CONSECUTIVE READINGS: 116 MG/DL AT 22:13 H AND 111 MG/DL AT 22:46 H. NO THIRD-PARTY MEDICAL INTERVENTION WAS REQUIRED. THE CUSTOMER REPORTEDLY ATE GLUCOSE TABLETS AND DRANK ORANGE JUICE TO COUNTERACT THE EVENT. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FREEDOM LITE BLOOD GLUCOSE MONITORING SYSTEM LFR ABBOTT DIABETES CARE INC., USA NA 0820826

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other