BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE

    MDR report key: 1772099 · Received June 27, 2007

    Report

    Report Number
    2954323-2007-11396
    Event Type
    Malfunction
    Date Received
    June 27, 2007
    Date of Event
    May 29, 2007
    Report Date
    June 27, 2007
    Manufacturer
    ABBOTT DIABETES CARE INC, USA
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED AN ISSUE WITH THEIR METER WHICH SUGGESTS THE MEMORY OVERWRITE MALFUNCTION HAS OCCURRED. THE PRODUCT HAS BEEN REQUESTED FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED IF THE METER IS RETURNED. CUSTOMERS AND RETAILERS HAVE BEEN INFORMED THROUGH THE FA16MAY2006 LETTER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE UNIT OF MEASUREMENT SETTING OF THEIR FREESTYLE BLOOD GLUCOSE MONITOR CHANGED FROM MG/DL TO MMOL/L WHICH SUGGESTS THE MEMORY OVERWRITE MALFUNCTION HAS OCCURRED. ADDITIONALLY, THE CUSTOMER STATED SHE DRANK ORANGE JUICE AND WAS EXPERIENCING DIZZINESS AND LIGHTHEADEDNESS. THERE WAS NO REPORT OF THIRD PARTY MEDICAL INTERVENTION, DEATH OR SERIOUS INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK