BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE LITE

    MDR report key: 2142520 · Received June 28, 2011

    Report

    Report Number
    2954323-2011-03688
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    June 14, 2011
    Report Date
    August 11, 2011
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S REPORTED PRODUCT WAS RETURNED AND AN INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. NOTES: THE METER IS DESIGNED TO REPORT READINGS OF 20 MG/DL TO 500 MG/DL. IT SHOULD BE NOTED THAT THIS METER DOES NOT GIVE NUMERIC VALUE FOR READINGS GREATER THAN 500 MG/DL. A "HI" DISPLAY MESSAGE INDICATES A READING GREATER THAN 500 MG/DL. THE DEVICE MANUFACTURE DATE IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS NOT CONFIRMED AND NO NEW ISSUES WERE OBSERVED. ALL FUNCTIONAL TEST RESULTS WERE WITHIN RANGE SPECIFICATION. NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING. THE READINGS THE CUSTOMER REPORTED WERE FOUND IN METER MEMORY.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON THEIR ADC BLOOD GLUCOSE MONITOR. CUSTOMER REPORTED RECEIVING READINGS OF "HI" (GREATER THAN 500 MG/DL) AND 89 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 1084224

    Patients

    Seq Age Sex Outcome Treatment
    1