BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FLASH

    MDR report key: 1810201 · Received October 9, 2007

    Report

    Report Number
    2954323-2007-19010
    Event Type
    Malfunction
    Date Received
    October 9, 2007
    Date of Event
    September 7, 2007
    Report Date
    October 9, 2007
    Manufacturer
    ABBOTT DIABETES CARE INC, USA
    Product Code
    LFR
    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 AN ISSUE WITH THEIR METER WHICH SUGGESTS THE MEMORY OVERWRITE MALFUNCTION HAS OCCURRED. CUSTOMER REPORTS SHE COULD NOT TEST WITH THEIR METER AND THAT SHE FELT HER BLOOD GLUCOSE LEVELS WERE LOW. THE CUSTOMER ALSO REPORTS THAT SHE EXPERIENCED SHAKINESS. CUSTOMER SELF-TREATED WITH CANDY, (B)(4) AND PROTEIN. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR THIRD PARTY MEDICAL INTERVENTION.

    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 0526002

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK