BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE LITE

    MDR report key: 1491988 · Received August 20, 2009

    Report

    Report Number
    2954323-2009-01583
    Event Type
    Malfunction
    Date Received
    August 20, 2009
    Date of Event
    July 21, 2009
    Report Date
    August 20, 2009
    Manufacturer
    ABBOTT DIABETES CARE INC, USA
    Product Code
    LFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. THE PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. THE FOLLOW-UP REPORT WILL BE SENT WHEN INVESTIGATIONAL RESULTS ARE AVAILABLE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON THEIR FREESTYLE LITE BLOOD GLUCOSE MONITOR. CUSTOMER REPORTED RECEIVING READINGS OF 225, 149, 23, 95, 154, 159, 210, 121, 133 MG/DL WITHIN 10 MINUTES. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL INTO A "C" ZONE SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. ALTHOUGH THE CUSTOMER ALSO REPORTED BEING SEEN BY A DOCTOR AND DIAGNOSED WITH HYPERGLYCEMIA, NO EMERGENT TREATMENT WAS REPORTED. THE CUSTOMER SELF-TREATED WITH HIS REGULAR DIABETIC MEDICATIONS. THE REPORTED READINGS ARE SUGGESTIVE OF HYPERGLYCEMIA, WHICH IS CONSISTENT WITH THE REPORTED DIAGNOSIS. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM LFR ABBOTT DIABETES CARE INC, USA NI 0907512

    Patients

    Seq Age Sex Outcome Treatment
    1 NI