BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE INSULINX

    MDR report key: 3841059 · Received May 30, 2014

    Report

    Report Number
    2954323-2014-00607
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 6, 2014
    Product Code
    NBW
    PMA / PMN Number
    K120568
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCTS HAVE BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE REPORTED METER WAS RETURNED AND INVESTIGATED WITH RETURNED TEST STRIPS LOT 1362862. 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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT ON (B)(6) 2014 SHE RECEIVED AN ER-3 MESSAGE ON THE DISPLAY OF HER ADC BLOOD GLUCOSE METER AFTER A SAMPLE WAS APPLIED TO A TEST STRIP INSERTED INTO IT. CUSTOMER FURTHER REPORTED EXPERIENCING "SHAKINESS, SWEATING, THIRST AND DIZZINESS". PARAMEDICS WERE CALLED AND UPON ARRIVAL TREATED CUSTOMER WITH A GLUCAGON INJECTION. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318485 FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEM NBW 1362862

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention