BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FLASH

    MDR report key: 1790181 · Received August 17, 2007

    Report

    Report Number
    2954323-2007-15193
    Event Type
    Malfunction
    Date Received
    August 17, 2007
    Date of Event
    July 20, 2007
    Report Date
    August 17, 2007
    Manufacturer
    ABBOTT DIABETES CARE INC, USA
    Product Code
    LFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    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 ADC FA16MAY2006 LETTER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT SHE WAS FEELING LIKE HER SUGAR WAS HIGH. SHE HAD SYMPTOMS OF ¿LIGHTHEADNESS, DIZZINESS AND BLURRED VISION¿ BECAUSE SHE WAS UNABLE TO TEST HER BLOOD SUGAR WITH HER FREESTYLE FLASH BLOOD GLUCOSE METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FLASH BLOOD GLUCOSE MONITORING SYSTEM LFR ABBOTT DIABETES CARE INC, USA NA 0612954

    Patients

    Seq Age Sex Outcome Treatment
    1 NA