BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FLASH

    MDR report key: 1801652 · Received September 7, 2007

    Report

    Report Number
    2954323-2007-16580
    Event Type
    Malfunction
    Date Received
    September 7, 2007
    Date of Event
    August 9, 2007
    Report Date
    September 7, 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). CUSTOMER RETURNED METER WITH SERIAL NUMBER: (B)(4). THE COMPLAINT IS UNDER INVESTIGATION AND A FOLLOW-UP REPORT WILL BE FILED ONCE THE INVESTIGATION IS COMPLETE. CUSTOMERS AND RETAILERS HAVE BEEN INFORMED THROUGH THE ADC FA16MAY2006 LETTER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING AN ERROR 4 WHEN A TEST STRIP WAS INSERTED AND A BATTERY AND BOOKLET ICONS APPEARED ON THE DISPLAY OF THEIR FREESTYLE FLASH BLOOD GLUCOSE MONITOR, WHICH SUGGESTS THE MEMORY OVERWRITE MALFUNCTION HAS OCCURRED. THE CUSTOMER MENTIONED SHE WAS NOT ABLE TO HAVE HER AND HER SON'S BLOOD GLUCOSE TESTED BECAUSE OF THE MALFUNCTION. SHE REPORTED THE FOLLOWING SYMPTOMS THAT BOTH EXPERIENCED: "SYMPTOMS OF HIGH AND LOW BLOOD GLUCOSE, DIZZINESS, FATIGUE AND WEAKNESS." THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR THIRD PARTY MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

    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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA