BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE NAVIGATOR

    MDR report key: 1973369 · Received January 30, 2011

    Report

    Report Number
    2954323-2011-01265
    Event Type
    Injury
    Date Received
    January 30, 2011
    Date of Event
    January 13, 2011
    Report Date
    March 4, 2011
    Manufacturer
    ABBOTT DIABETES CARE INC.
    Product Code
    LFR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. NOTE: THE DEVICE MANUFACTURE DATE IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    THE FOLLOWING PRODUCTS WERE RETURNED: FREESTYLE NAVIGATOR RECEIVER SERIAL # (B)(4) AND TRANSMITTER # (B)(4). FREESTYLE NAVIGATOR RECEIVER PASSED THE AUTOMATED TEST. COMPLAINT WAS NOT CONFIRMED. CORRECTION: THE COUNTRY OF THE ORIGINAL REPORTER (E1) IS (B)(6) AND NOT (B)(6).

    Description of Event or Problem · 1

    A DIABETIC NURSE REPORTED THE CUSTOMER HAD A FREESTYLE NAVIGATOR SYSTEM AND THE ALARM FOR A LOW READING DID NOT SOUND DURING THE NIGHT. THE CUSTOMER WAS FOUND UNCONSCIOUS IN THE MORNING AND A RELATIVE CALLED THE AMBULANCE. THE PARAMEDICS TESTED THE CUSTOMER'S BLOOD GLUCOSE AND AFTER OBTAINING A READING OF 2.4 MMOL/L, THEY TREATED THE CUSTOMER WITH GLUCOSE INTRAVENOUSLY. THE CUSTOMER WAS NOT REPORTEDLY TRANSPORTED TO A HEALTH CARE FACILITY AND NO FURTHER INFORMATION ABOUT THE EVENT IS AVAILABLE. 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 NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM LFR ABBOTT DIABETES CARE INC. AAAP251-80103

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R