BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE LITE

    MDR report key: 1802311 · Received August 17, 2010

    Report

    Report Number
    2954323-2010-01120
    Event Type
    Malfunction
    Date Received
    August 17, 2010
    Date of Event
    July 26, 2010
    Report Date
    September 21, 2010
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER'S PRODUCT WAS RETURNED AND INVESTIGATED. 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. THE READINGS THE CUSTOMER REPORTED WERE FOUND IN METER MEMORY. THIS IS A FINAL REPORT.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE FILED ONCE INVESTIGATION RESULTS ARE AVAILABLE.

    Description of Event or Problem · 1

    CUSTOMER'S SON-IN-LAW REPORTED THAT ON (B)(6) 2010 CUSTOMER RECEIVED A READING OF 234 MG/DL ON HIS FREESTYLE LITE BLOOD GLUCOSE METER. IT WAS FURTHER REPORTED CUSTOMER BECAME UNRESPONSIVE, HAD SLURRED SPEECH, WAS UNABLE TO RECOGNIZE FAMILY MEMBERS AND HAD "NO MOTOR SKILLS". CUSTOMER WAS TAKEN BY FAMILY MEMBERS TO A LOCAL HEALTHCARE FACILITY WHERE A RESULT OF 30 MG/DL WAS OBTAINED ON AN UNKNOWN BRAND OF METER. CUSTOMER WAS DIAGNOSED WITH SEVERE HYPOGLYCEMIA AND REPORTEDLY TREATED WITH INSULIN. IT IS UNKNOWN HOW MUCH TIME HAD ELAPSED BETWEEN WHEN THE READING OF 234 MG/DL WAS RECEIVED AND THE READING OF 30 MG/DL. TWO UNSUCCESSFUL ATTEMPTS HAVE BEEN MADE TO CONTACT THE CUSTOMER IN AN ATTEMPT TO CLARIFY THE TREATMENT THE CUSTOMER RECEIVED AND TIMEFRAME IN WHICH THE EVENT OCCURRED. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON THEIR ADC BLOOD GLUCOSE METER. CUSTOMER REPORTED RECEIVING READINGS OF 20 MG/DL AND 129 MG/DL WITHIN 10 MINUTES. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL INTO THE "C" ZONE SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. 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 NBW 1010436

    Patients

    Seq Age Sex Outcome Treatment
    1