BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE PRECISION NEO

    MDR report key: 4785832 · Received May 20, 2015

    Report

    Report Number
    2954323-2015-00267
    Event Type
    Injury
    Date Received
    May 20, 2015
    Date of Event
    April 29, 2015
    Report Date
    August 14, 2015
    Manufacturer
    ABBOTT DIABETES CARE INC.
    Product Code
    NBW
    PMA / PMN Number
    K140371
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE- DUPLICATE RESULT AND CONCLUSION CODES WERE ENTERED IN THE EVALUATION CODES SECTION DUE TO AN ERROR RECEIVED DURING ATTEMPTED SUBMISSION INDICATING "NI" IS NOT A VALID ENTRY. THE REPORTED METER WAS RETURNED AND INVESTIGATED WITH CONTROLLED 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.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S PRODUCTS HAVE BEEN REQUESTED FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE FILED ONCE ADDITIONAL INFORMATION IS OBTAINED. NOTE: THE DATE OF EVENT IS UNKNOWN. THE EVENT DATE ENTERED IS THE DATE ABBOTT DIABETES CARE BECAME AWARE OF THE EVENT. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    CUSTOMER, WHO IS A HEALTHCARE PROFESSIONAL, REPORTED THAT SOME TIME AT (B)(6) 2015, WHILE ON A CAMPING TRIP ABROAD, SHE BEGAN TO "SWEAT AND SHAKE", BUT WHEN SHE ATTEMPTED TO PERFORM A TEST USING HER ADC BLOOD GLUCOSE METER THE TEST DID NOT START AND THEN THE METER TURNED OFF. CUSTOMER'S FAMILY MEMBER ADMINISTERED A GLUCAGON INJECTION. NO ADDITIONAL TREATMENT WAS RENDERED. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328658 FREESTYLE PRECISION NEO BLOOD GLUCOSE MONITORING SYSTEM NBW ABBOTT DIABETES CARE INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention