BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE

    MDR report key: 1781653 · Received June 21, 2007

    Report

    Report Number
    2954323-2007-10977
    Event Type
    Malfunction
    Date Received
    June 21, 2007
    Date of Event
    May 22, 2007
    Report Date
    June 21, 2007
    Manufacturer
    ABBOTT DIABETES CARE INC, USA
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER'S PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE FILED ONCE INVESTIGATION RESULTS ARE AVAILABLE. CUSTOMERS AND RETAILERS HAVE BEEN INFORMED THROUGH THE ADC FA16MAY2006 LETTER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING AN ERROR 3 WHEN A TEST STRIP WAS INSERTED AND A BATTERY AND BOOKLET ICON APPEARED ON THE DISPLAY OF THEIR FREESTYLE BLOOD GLUCOSE MONITOR. ALTHOUGH, THE METER WAS SET TO THE CORRECT UNIT OF MEASURE, THE METER IS EXHIBITING SIGNS OF THE MEMORY OVERWRITE MALFUNCTION. CUSTOMER ALSO REPORTED EXPERIENCING SYMPTOMS OF DIZZINESS AND WEAKNESS. THERE WAS NO THIRD-PARTY MEDICAL INTERVENTION. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM NBW ABBOTT DIABETES CARE INC, USA NA 0615712

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK