BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE

    MDR report key: 1800851 · Received September 21, 2007

    Report

    Report Number
    2954323-2007-17736
    Event Type
    Malfunction
    Date Received
    September 21, 2007
    Date of Event
    August 23, 2007
    Report Date
    September 21, 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 PRODUCT HAS BEEN RETURNED AND AN INVESTIGATION IS IN PROCESS. CUSTOMERS AND RETAILERS HAVE BEEN INFORMED THROUGH THE ADC FA16MAY2006 LETTER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN ISSUE WITH THEIR METER WHICH SUGGESTS THE MEMORY OVERWRITE MALFUNCTION HAS OCCURRED. CUSTOMER REPORTS SYMPTOMS OF DIZZINESS AND SELF TREATED AT HOME, THERE WAS NO THIRD PARTY MEDICAL ATTENTION REQUIRED. THERE WAS NO REPORT OF 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 0709617

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK