BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FREEDOM

    MDR report key: 1020148 · Received May 25, 2007

    Report

    Report Number
    2954323-2007-08863
    Event Type
    Malfunction
    Date Received
    May 25, 2007
    Date of Event
    April 24, 2007
    Report Date
    May 25, 2007
    Manufacturer
    ABBOTT DIABETES CARE INC.
    Product Code
    LFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S METER AND TEST STRIPS WERE RETURNED. CONTROL SOLUTION TESTING WAS PERFORMED. ALL RESULTS FELL WITHIN THE ASSIGNED RANGE. THE READINGS WERE IN THE CORRECT UNIT OF MEASUREMENT. NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING. THE CUSTOMER'S COMPLAINT OF IMPRECISE SEQUENTIAL READINGS COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THEY OBTAINED IMPRECISE SEQUENTIAL READINGS ON THEIR FREESTYLE FREEDOM BLOOD GLUCOSE MONITOR. THE CUSTOMER OBTAINED READINGS OF 23.1 MMOL/L, 1.4 MMOL/L, 14.8 MMOL/L, 22.6 MMOL/L AND 7.4 MMOL/L. DUE TO THE HIGH READINGS ON HER METER, THE CUSTOMER INJECTED TOO MUCH INSULIN AND THEREFORE EXPERIENCED SYMPTOMS OF HYPOGLYCEMIA. THE CUSTOMER WAS PALE AND SHAKY. THE CUSTOMER TOOK GLUCOSE TABLETS AND DRANK JUICE. THE READINGS OF 14.8 MMOL/L, 22.6 MMOL/L AND 7.4 MMOL/L WERE TAKEN WITHIN A TEN MINUTE TIMEFRAME. WHEN PLOTTED ON A PARKES ERROR GRID ONE OF THE RESULTS FELL IN THE 'C' ZONE. THIS DIFFERENCE IN READINGS IS CONSIDERED CLINICALLY SIGNIFICANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FREEDOM BLOOD GLUCOSE MONITORING SYSTEM LFR ABBOTT DIABETES CARE INC. NA 0626120

    Patients

    Seq Age Sex Outcome Treatment
    1 NI