BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE

    MDR report key: 1800204 · Received August 29, 2007

    Report

    Report Number
    2954323-2007-15885
    Event Type
    Malfunction
    Date Received
    August 29, 2007
    Date of Event
    July 30, 2007
    Report Date
    August 29, 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 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 AN ISSUE WITH THEIR METER, WHICH SUGGESTS THE MEMORY OVERWRITE MALFUNCTION HAS OCCURRED. THERE WAS NO REPORT OF DEATH OR SERIOUS INJURY. HOWEVER, CUSTOMER REPORTED HE CHANGED HIS INSULIN TREATMENT BASED UPON NOT RECEIVING A RESULT FROM HIS METER. HE REPORTED SYMPTOMS INCLUDING "DEHYDRATION, FATIGUE, BODY FELT HOT AND VOMITING." HE REPORTEDLY ATE A CHOCOLATE DOUGHNUT TO TREAT HIS SYMPTOMS. HE DID NOT REQUIRE THIRD PARTY MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM NBW ABBOTT DIABETES CARE INC, USA NI 0427205

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK