BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 1810297 · Received August 20, 2010

    Report

    Report Number
    2954323-2010-01148
    Event Type
    Injury
    Date Received
    August 20, 2010
    Date of Event
    August 2, 2010
    Report Date
    October 19, 2010
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. THE CUSTOMER'S PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE FILED ONCE INVESTIGATION RESULTS ARE AVAILABLE. NOTE: THE REPORTED READINGS WERE OBTAINED WITHIN TEN MINUTES. THE RESULTS WERE PLOTTED ON A PARKES ERROR GRID AND FELL INTO THE "A" ZONE SHOWING THE DIFFERENCE IN VALUES WAS NOT CLINICALLY SIGNIFICANT.

    Additional Manufacturer Narrative · 1

    REQUESTED PRODUCT WAS NOT RECEIVED FOR INVESTIGATION. RETAINED TEST STRIP SAMPLES FROM THE SAME LOT REPORTED BY THE CUSTOMER (B)(4) WERE TESTED WITH CONTROL SOLUTION INSTEAD. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED. THE COMPLAINT IS NOT CONFIRMED. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING THE METER DOES NOT POWER ON. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WERE NO ALLEGATIONS OF HARM OR INJURY. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING ERRATIC READINGS OF 284 MG/DL AND 223 MG/DL FROM HIS FREESTYLE FREEDOM LITE METER WHICH WERE HIGHER THAN HE FELT. CUSTOMER ALSO REPORTED TAKING HIS INSULIN MEDICATION ACCORDING TO HIS GLUCOSE READINGS THEN LOST CONSCIOUSNESS. CUSTOMER FURTHER REPORTED EATING FOOD AND DRINKING MILK AND TAKING HIS GLUCOSE PILLS TO COUNTERACT HIS SYMPTOMS. CUSTOMER REPORTED VISITING HIS DOCTOR WHO DIAGNOSED CUSTOMER WITH SEVERE HYPOGLYCEMIA AND BANDAGED HIS ARM THAT HE INJURED WHEN HE LOST CONSCIOUSNESS. THERE WAS 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 1011614

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R