BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE MINI

    MDR report key: 890928 · Received October 25, 2006

    Report

    Report Number
    2954323-2006-01122
    Event Type
    Malfunction
    Date Received
    October 25, 2006
    Date of Event
    June 23, 2006
    Report Date
    October 25, 2006
    Manufacturer
    ABBOTT DIABETES CARE INC.
    Product Code
    LFR
    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. TESTED RETURNED UNIT. NO MFG PARAMETERS FOUND OUT OF SPEC. RETURNED PANASONIC BATTERY DID NOT POWER ON METER. REPLACED WITH CIG BATTERY AND METER POWER ON SUCCESSFULLY. DID NOT OBSERVE BATTERY ICON OR BOOKLET ICON WHILE STRIP WAS INSERTED. UOM WAS RETURNED IN MG/DL WHEN RECEIVED. THE 0300 AND 0806 ERRORS WERE OBSERVED IN THE ERROR LOG INDICATING BATTERY DROP.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE MINI BLOOD GLUCOSE MONITORING SYSTEM LFR ABBOTT DIABETES CARE INC. 70658-02 *

    Patients

    Seq Age Sex Outcome Treatment
    1 YR