BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FLASH

    MDR report key: 1031979 · Received April 18, 2008

    Report

    Report Number
    2954323-2008-01522
    Event Type
    Malfunction
    Date Received
    April 18, 2008
    Date of Event
    March 22, 2008
    Report Date
    April 18, 2008
    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

    THE COMPLAINT WAS NOT CONFIRMED AND NO NEW ISSUES WERE OBSERVED, ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING. ACCORDING TO THE RETURNED METER, THE VALUES CUSTOMER RECEIVED WERE FOUND IN THE METER'S INTERNAL LOG AND WERE OBTAINED IN 2008.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON THEIR FREESTYLE FLASH BLOOD GLUCOSE MONITOR. CUSTOMER REPORTED RECEIVING READINGS OF 75 MG/DL, 321 MG/DL AND 476 MG/DL WITHIN 10 MINUTES. ALL TESTS WERE PERFORMED ON THE FINGER. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL INTO THE "C" ZONES SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MISTREATMENT ASSOCIATED WITH THIS EVENT. NOTE: CUSTOMER DOES NOT RECALL WHETHER THEY WASHED THEIR HANDS. NOT WASHING HANDS BEFORE TESTING IS A KNOWN CAUSE OF IMPRECISE READINGS.

    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 0631345

    Patients

    Seq Age Sex Outcome Treatment
    1 NA