BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE

    MDR report key: 1020060 · Received May 25, 2007

    Report

    Report Number
    2954323-2007-08950
    Event Type
    Malfunction
    Date Received
    May 25, 2007
    Date of Event
    April 30, 2007
    Report Date
    May 25, 2007
    Manufacturer
    ABBOTT DIABETES CARE INC.
    Product Code
    LFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S METER WAS RETURNED FOR INVESTIGATIONS. THE TEST STRIPS WERE NOT RETURNED. THE CUSTOMER'S METER WAS SET AT MMOL/L WHEN RETURNED BY THE CUSTOMER. ALL RESULTS WERE WITHIN THE RANGE SPEC AND NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING. THE CUSTOMER'S COMPLAINT OF IMPRECISE SEQUENTIAL READINGS COULD NOT BE CONFIRMED ON THE METER.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THEY OBTAINED IMPRECISE SEQUENTIAL READINGS ON THEIR FREESTYLE BLOOD GLUCOSE MONITOR. THE CUSTOMER FELT UNWELL AND OBTAINED READINGS OF 17.2 MMOL/L ON THE METER FOLLOWED BY 3.1 MMOL/L WITHIN A 10 MINUTE TIMEFRAME. WHEN PLOTTED ON A PARKES ERROR GRID THE RESULTS FELL IN THE 'C' ZONE. THIS DIFFERENCE IN READINGS IS CONSIDERED CLINICALLY SIGNIFICANT. THE CUSTOMERS REPORTED FEELING TINGLY AND SLIGHTLY SWEATY. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MISTREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM LFR ABBOTT DIABETES CARE INC. NA 0632426

    Patients

    Seq Age Sex Outcome Treatment
    1 NI