BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE NAVIGATOR

    MDR report key: 2133016 · Received June 17, 2011

    Report

    Report Number
    2954323-2011-03596
    Event Type
    Injury
    Date Received
    June 17, 2011
    Date of Event
    June 10, 2011
    Report Date
    July 8, 2011
    Product Code
    MDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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 OBTAINED. THE DATE OF MANUFACTURE IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S RECEIVER WAS RETURNED AND INVESTIGATED AND THE COMPLAINT WAS NOT CONFIRMED. NO NEW ISSUES WERE OBSERVED. ALL FUNCTIONAL TEST RESULTS WERE WITHIN RANGE SPECIFICATION. NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT ON (B)(6) 2011 HE RECEIVED A READING OF 472 MG/DL (26.2 MMOL/L) ON HIS FREESTYLE NAVIGATOR CONTINUOUS MONITORING SYSTEM WHICH HE COMPARED TO A READING OF 168 MG/DL (9.3 MMOL/L) RECEIVED ON A COMPETITOR'S METER. CUSTOMER FURTHER REPORTED HE SELF-ADMINISTERED AN UNKNOWN AMOUNT OF INSULIN IN RESPONSE TO THE READING OF 26.2MMOL/L AND SUBSEQUENTLY EXPERIENCED UNSPECIFIED HYPOGLYCEMIC SYMPTOMS, WHICH RESULTED IN A LOSS OF CONSCIOUSNESS AND A "COMA". CUSTOMER ADDITIONALLY REPORTED SUSTAINING A BUMP ON HIS HEAD, A PAINFUL HIP AND A "BLACK EYE". NO THIRD-PARTY EMERGENT MEDICAL INTERVENTION WAS REPORTED. CUSTOMER SELF-TREATED BY SELF-ADMINISTERING A GLUCAGON INJECTION AND EATING BREAD AND SUGAR. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM MDS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1