BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 1971225 · Received January 26, 2011

    Report

    Report Number
    2954323-2011-01124
    Event Type
    Malfunction
    Date Received
    January 26, 2011
    Date of Event
    December 20, 2010
    Report Date
    February 23, 2011
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S PRODUCTS HAVE BEEN REQUESTED AND RECEIVED AND AN INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL REPORT WILL BE SENT ONCE NEW INFORMATION IS OBTAINED. THE METER'S MANUFACTURE DATE IS UNKNOWN.

    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. THE READINGS THE CUSTOMER REPORTED WERE NOT FOUND IN METER MEMORY. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    AN ADC CUSTOMER REPORTED RECEIVING IMPRECISE METER READINGS USING THEIR FS FREEDOM LITE METER. THEY REPORTED RECEIVING READINGS OF 287MG/DL, 31MG/DL AND 116MG/DL OBTAINED WITHIN A TEN MINUTE TIMEFRAME. WHEN PLOTTED ON THE PARKES ERROR GRID THE RESULTS FELL WITHIN THE "C" ZONE SHOWING THE DIFFERENCE IN VALUES IS CONSIDERED CLINICALLY SIGNIFICANT. IN ADDITION, THE CUSTOMER REPORTED THAT AS A RESULT OF THE READINGS THEY DID NOT EAT AND EXPERIENCED SYMPTOMS OF FEELING "LIGHTHEADED, NAUSEA AND WEAKNESS". NO THIRD PARTY MEDICAL INTERVENTION WAS REPORTED AND CUSTOMER REPORTEDLY ATE FOOD TO HELP ALLEVIATE HIS SYMPTOMS. THERE WAS NO REPORT OF SERIOUS INJURY, DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FREEDOM LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1078133

    Patients

    Seq Age Sex Outcome Treatment
    1