BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 1991228 · Received February 15, 2011

    Report

    Report Number
    2954323-2011-01629
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    January 24, 2011
    Report Date
    April 22, 2011
    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 CUSTOMER'S PRODUCTS HAVE BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED.

    Additional Manufacturer Narrative · 1

    REQUESTED PRODUCT WAS NOT RECEIVED FOR INVESTIGATION. RETAINED TEST STRIP SAMPLES FROM THE SAME LOT REPORTED BY THE CUSTOMER (1022503) 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'S WIFE REPORTED THAT ON (B)(6) 2011 CUSTOMER RECEIVED ERRATIC READINGS ON HIS FREESTYLE FREEDOM LITE BLOOD GLUCOSE METER. CUSTOMER REPORTED RECEIVING READINGS OF 280 MG/DL AND 34 MG/DL WITHIN 10 MINUTES. ALL TESTS WERE PERFORMED ON THE FINGER. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL INTO THE "C" ZONE SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. IT WAS FURTHER REPORTED CUSTOMER EXPERIENCED DIAPHORESIS, FEELING HOT, FELT "SICK TO STOMACH" AND NOTICED HIS HEART WAS FLUTTERING. PARAMEDICS WERE CALLED, MONITORED HIS CARDIAC STATUS, CHECKED HIS BLOOD GLUCOSE (NO RESULTS PROVIDED) AND TRANSPORTED CUSTOMER TO A LOCAL HEALTHCARE FACILITY. CUSTOMER WAS DIAGNOSED WITH SEVERE HYPERGLYCEMIA AND TREATED WITH 14 UNITS OF INSULIN. CUSTOMER ADDITIONALLY SELF-TREATED BY TAKING AN ASPIRIN. 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 FREEDOM LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1022503

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention