BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 2701238 · Received August 15, 2012

    Report

    Report Number
    2954323-2012-06486
    Event Type
    Injury
    Date Received
    August 15, 2012
    Date of Event
    July 16, 2012
    Report Date
    July 18, 2012
    Product Code
    NBW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REQUESTED PRODUCT WAS NOT RECEIVED FOR INVESTIGATION. RETAINED TEST STRIP SAMPLES FROM THE SAME LOT REPORTED BY THE CUSTOMER (1183219) WERE TESTED WITH CONTROL SOLUTION INSTEAD. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED. THE COMPLAINT IS NOT CONFIRMED.

    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. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON HIS ADC GLUCOSE METER. READINGS OF 389 MG/DL AND 39 MG/DL WERE OBTAINED WITHIN 10 MINUTES ON (B)(6) 2012 AT 10PM. WHEN PLOTTED ON A PARKES ERROR GRID, THE RESULTS FELL INTO THE "C" ZONE, INDICATING THE DIFFERENCE IN VALUES WAS CLINICALLY SIGNIFICANT. AS A RESULT OF THIS ISSUE, THE CUSTOMER REPORTED THAT AT 4:30 AM ON (B)(6) 2012, HE WAS IN BED SLEEPING WHEN HIS WIFE NOTICED HE WAS "SWEATING A LOT". THE CUSTOMER REPORTED HE WAS "OUT OF IT" AND THAT HE EXPERIENCED A LOSS OF CONSCIOUSNESS. THE CUSTOMER'S WIFE "FLIPPED THE BED UP" AND GAVE THE CUSTOMER "ORANGE JUICE AND CINNAMON TOAST." THE CUSTOMER SELF-PRESENTED TO A HEALTH CARE FACILITY 2 DAYS LATER, HOWEVER NO TREATMENT OR DIAGNOSES WERE REPORTED. THE CUSTOMER STATED HE WAS ADVISED TO CONTACT THE "METER COMPANY." 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 1183219

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other