BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FLASH

    MDR report key: 835107 · Received November 1, 2006

    Report

    Report Number
    2954323-2006-01182
    Event Type
    Malfunction
    Date Received
    November 1, 2006
    Date of Event
    August 7, 2006
    Report Date
    November 1, 2006
    Manufacturer
    ABBOTT DIABETES CARE INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER HAS BEEN CONFIRMED TO EXHIBIT THE MEMORY OVERWRITE MALFUNCTION. NO MFG PARAMETERS FOUND OUT OF SPEC. ORIGINAL PANASONIC BATTERY DID NOT POWER ON METER. REPLACED WITH FRESH BATTERY. DID NOT OBSERVE BATTERY ICON OR BOOKLET ICON WHILE STRIP WAS INSERTED. HOWEVER, OUM WAS SELECTABLE AND WAS RECEIVED AT MG/DL. THE 0204, 0300, 0800, AND 0806 ERRORS WERE OBSERVED IN THE ERROR LOG INDICATING BATTERY DROP. CUSTOMERS AND RETAILERS HAVE BEEN INFORMED THROUGH THE FA16MAY2006 LETTER.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE UNIT OF MEASUREMENT SETTING OF THEIR FREESTYLE FLASH METER CHANGED FROM MMOL/L TO MG/DL. THERE WAS NO REPORTS OF DEATH, SERIOUS INJURY OR MISTREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FLASH BLOOD GLUCOSE MONITORING SYSTEM NBW ABBOTT DIABETES CARE INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 YR