BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLUCOMMANDER

    MDR report key: 6801845 · Received August 17, 2017

    Report

    Report Number
    3005853093-2017-00001
    Event Type
    Malfunction
    Date Received
    August 17, 2017
    Date of Event
    July 24, 2017
    Report Date
    August 17, 2017
    Manufacturer
    GLYTEC, LLC
    Product Code
    NDC
    UDI-DI
    0086005700305
    PMA / PMN Number
    K113853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A PATCH WAS CREATED IN VERSIONS 3.3.1.8 AND 3.3.4.2, WHICH WERE RELEASED AUGUST 11, 2017. THE 3 AFFECTED CLIENTS WILL BE UPGRADED AS SOON AS POSSIBLE.

    Description of Event or Problem · 1

    BEDTIME HYPOGLYCEMIA RECHECK BG RECOMMENDS INSULIN DOSE WHEN IT SHOULD NOT - FOLLOWING A BEDTIME HYPOGLYCEMIA BG TREATED WITH ALTERNATIVE HYPOGLYCEMIC TREATMENT OF 12-15 GRAMS OF CARBOHYDRATE WITH SNACKING DISABLED, A RECHECK BG RECOMMENDS A SNACK INSULIN DOSE. THERE IS NO EVIDENCE OF ADVERSE EVENTS RESULTING FROM THIS BUG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580674 GLUCOMMANDER PREDICTIVE PULMONARY FUNCTION VALUE NDC GLYTEC, LLC 3.1.0.0 0086005700305

    Patients

    Seq Age Sex Outcome Treatment
    1