BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 2252329 · Received September 17, 2011

    Report

    Report Number
    2954323-2011-04518
    Event Type
    Injury
    Date Received
    September 17, 2011
    Date of Event
    August 25, 2011
    Report Date
    June 26, 2012
    Product Code
    NBW
    Adverse Event
    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

    THE REPORTED METER WAS RETURNED AND INVESTIGATED WITH RETAINED TEST STRIPS. THE COMPLAINT WAS NOT CONFIRMED AND NO NEW ISSUES WERE OBSERVED. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING. THE REPORTED READINGS WAS FOUND IN METER MEMORY. (B)(4)

    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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED RECEIVING A READING ON HIS FREESTYLE METER OF 226 MG/DL AT 8:00PM ON (B)(6) 2011. THE CUSTOMER FURTHER REPORTED HE OBTAINED A AN INTERSTITIAL FLUID (ISF) READING OF 130 MG/DL AT 8:00PM ON HIS DEXCOM CONTINUOUS GLUCOSE MONITOR, AND THAT "HE USED THE READING OF 226 MG/DL FROM HIS FREESTYLE METER TO CALIBRATE HIS DEXCOM" CGM. THE CUSTOMER STATED "HE FEELS HIS FREESTYLE LITE METER IS READING HIGHER THAN HE REALLY IS BECAUSE HE HAD A LOW REACTION (B)(6)." THE CUSTOMER EXPLAINED "HE RELIGIOUSLY USES HIS FS LITE METER TO CALIBRATE HIS CONTINUOUS GLUCOMETER TWICE A DAY". THE CUSTOMER REPORTED HE EXPERIENCED A SEIZURE AND LOSS OF CONSCIOUSNESS AT APPROXIMATELY 2:30AM ON (B)(6) 2011 AND SELF-TREATED WITH (B)(6). NO THIRD PARTY MEDICAL INTERVENTION WAS REPORTED. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1158305

    Patients

    Seq Age Sex Outcome Treatment
    1 Other