BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 2381875 · Received December 19, 2011

    Report

    Report Number
    2954323-2011-05457
    Event Type
    Injury
    Date Received
    December 19, 2011
    Date of Event
    December 4, 2011
    Report Date
    March 9, 2012
    Product Code
    NBW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. THE PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS AVAILABLE.

    Additional Manufacturer Narrative · 1

    REQUESTED PRODUCT WAS NOT RECEIVED FOR INVESTIGATION. RETAINED TEST STRIP SAMPLES FROM THE SAME LOT REPORTED BY THE CUSTOMER (1172226) 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

    A CUSTOMER'S FAMILY MEMBER REPORTED THAT THE CUSTOMER WAS RECEIVING ERRATIC READINGS ON HIS ADC METER. READINGS OF 438 MG/DL, 389 MG/DL, 376 MG/DL, 175 MG/DL AND HI (>500 MG/DL) WERE REPORTED. ALL TESTS WERE PERFORMED ON THE FINGER. WHEN PLOTTED ON A PARKES ERROR GRID, THE RESULTS FELL INTO THE "C" ZONE, INDICATING THAT THE DIFFERENCE IN VALUES WAS CLINICALLY SIGNIFICANT. AS A RESULT THIS ISSUE, THE CALLER STATED THAT ON (B)(6), 2011 AT 5:00PM THE CUSTOMER "FELL DOWN FROM DIZZINESS", AND EXPERIENCED A LOSS OF CONSCIOUSNESS "BECAUSE HE DID NOT KNOW HOW MUCH INSULIN TO TAKE DUE TO THE READINGS HE GOT". NO THIRD-PARTY MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER SELF-TREATED WITH "A DIET COKE". THERE IS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FREEDOM LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1172226

    Patients

    Seq Age Sex Outcome Treatment
    1 Other