BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FREEDOM

    MDR report key: 1802167 · Received August 24, 2007

    Report

    Report Number
    2954323-2007-15631
    Event Type
    Malfunction
    Date Received
    August 24, 2007
    Date of Event
    July 27, 2007
    Report Date
    August 24, 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 READINGS THAT WERE LOWER THAN HOW THEY FELT. DURING THE COURSE OF TROUBLESHOOTING WITH ADC CUSTOMER SERVICE, IT WAS DISCOVERED THAT THE UNIT OF MEASURE WAS SET TO MMOL/L INSTEAD OF MG/DL. 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 FREEDOM BLOOD GLUCOSE MONITORING SYSTEM NBW ABBOTT DIABETES CARE INC, USA NA 0517308

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK