BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLUCOMMANDER

    MDR report key: 6173544 · Received December 14, 2016

    Report

    Report Number
    3005853093-2016-00003
    Event Type
    Malfunction
    Date Received
    December 14, 2016
    Date of Event
    November 18, 2016
    Report Date
    December 14, 2016
    Manufacturer
    GLYTEC, LLC
    Product Code
    BTY
    UDI-DI
    00860057000305
    PMA / PMN Number
    K113853
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION AROUND THE PATIENT WAS REQUESTED BUT NOT RECEIVED. A PATCH WAS CREATED IN VERSION 3.3.1.3A, WHICH WAS RELEASED (B)(6) 2016. THE CLIENT WAS UPGRADED WITH THE PATCH ON (B)(6) 2016. THIS IS THE ONLY CLIENT AFFECTED.

    Description of Event or Problem · 1

    A HEALTH CARE PROFESSIONAL REPORTED THAT A PATIENT EXPERIENCED A BG OF 46 MG/DL AND ASKED THAT IT BE INVESTIGATED. UPON REVIEWING THE PATIENT IT WAS NOTED THAT THE I:C RATIO ADJUSTED WITH THE FIRST BG AFTER TRANSITION AS WELL AS ADJUSTING TWICE DURING A "WAITING TO EAT" MEAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824310 GLUCOMMANDER PREDICTIVE PULMONARY FUNCTION VALUE CALCULATOR BTY GLYTEC, LLC 3.3.1.3 00860057000305

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention