BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FLASH

    MDR report key: 1801019 · Received September 21, 2007

    Report

    Report Number
    2954323-2007-17710
    Event Type
    Malfunction
    Date Received
    September 21, 2007
    Date of Event
    August 22, 2007
    Report Date
    September 21, 2007
    Manufacturer
    ABBOTT DIABETES CARE INC, USA
    Product Code
    LFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE METER HAS BEEN CONFIRMED TO EXHIBIT THE MEMORY OVERWRITE MALFUNCTION. CUSTOMERS AND RETAILERS HAVE BEEN INFORMED THROUGH THE FA16MAY2006 LETTER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN ISSUE WITH THEIR METER. UPON INVESTIGATION, THE METER WAS FOUND TO EXHIBIT THE MEMORY OVERWRITE MALFUNCTION. THERE WAS NO REPORT OF DEATH OR SERIOUS INJURY. HOWEVER, ON (B)(6) 2007, THE CUSTOMER NOTED THAT BECAUSE SHE COULD NOT TEST SHE EXPERIENCED THE FOLLOWING SYMPTOMS: "LIGHTHEADEDNESS, NUMBNESS OF THE TONGUE, FAINTNESS AND BLURRED VISION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FLASH BLOOD GLUCOSE MONITORING SYSTEM LFR ABBOTT DIABETES CARE INC, USA NI 0626624

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK