BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE LITE

    MDR report key: 2914538 · Received January 14, 2013

    Report

    Report Number
    2954323-2013-00021
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    December 18, 2012
    Report Date
    December 21, 2012
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED. NOTE: THE METER IS DESIGNED TO DISPLAY READINGS OF 20 MG/DL TO 500 MG/DL. THIS METER DOES NOT SHOW A NUMERIC VALUE GREATER THAN 500 MG/DL. A BLOOD GLUCOSE READING ABOVE 500 MG/DL WILL READ AS A "HI" IN THE ADC METER.

    Additional Manufacturer Narrative · 1

    REQUESTED PRODUCT WAS NOT RECEIVED FOR INVESTIGATION. RETAINED TEST STRIP SAMPLES FROM THE SAME LOT REPORTED BY THE CUSTOMER (1267251) WERE TESTED WITH CONTROL SOLUTION INSTEAD. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED. THE COMPLAINT IS NOT CONFIRMED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON THEIR ADC BLOOD GLUCOSE METER. CUSTOMER REPORTED RECEIVING READINGS OF "HI" (GREATER THAN 500 MG/DL), 98 MG/DL, 379 MG/DL AND 109 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
    20426 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1267251

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR