BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE

    MDR report key: 2042744 · Received April 6, 2011

    Report

    Report Number
    2954323-2011-02855
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    March 15, 2011
    Report Date
    April 29, 2011
    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 INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS NOT CONFIRMED AND NO NEW ISSUES WERE OBSERVED. ALL FUNCTIONAL TEST RESULTS WERE WITHIN RANGE SPECIFICATION. NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING. THE READINGS THE CUSTOMER REPORTED WERE FOUND IN METER MEMORY.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED GETTING READINGS OF 379MG/DL, 352MG/DL, 389MG/DL, 399MG/DL AND 428MG/DL ON THEIR FREESTYLE METER THAT THEY PERCEIVED AS HIGHER THAN THEY FELT AND ERRATIC, HOWEVER, THE READINGS WERE NOT OBTAINED WITHIN 10 MINUTES, HENCE ARE INVALID FOR COMPARISON. THE CUSTOMER FURTHER REPORTED SELF-MEDICATING WITH INSULIN OFF OF THOSE READINGS, WHICH RESULTED IN "SEVERAL INSULIN ATTACKS" WITH SUBSEQUENT LOSS OF CONSCIOUSNESS THAT OCCURRED ON (B)(6) 2011 BETWEEN 12-1PM, (B)(6) 2011 AT 1:30-2:30PM AND (B)(6) 2011 AT 1:30PM. THE CUSTOMER REPORTEDLY SELF-TREATED BY EATING FOOD TO COUNTERACT THE EVENTS. NO THIRD-PARTY MEDICAL INTERVENTION WAS REPORTED. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM NBW 1007721

    Patients

    Seq Age Sex Outcome Treatment
    1 Other