BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLUCOMMANDER

    MDR report key: 8766020 · Received July 7, 2019

    Report

    Report Number
    3005853093-2019-00002
    Event Type
    Malfunction
    Date Received
    July 7, 2019
    Date of Event
    June 9, 2019
    Report Date
    July 3, 2019
    Manufacturer
    GLYTEC, LLC.
    Product Code
    NDC
    UDI-DI
    00860057000305
    PMA / PMN Number
    K113853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INTERRUPTION AND THE DATA ANOMALIES WERE DETERMINED NOT TO BE CAUSED BY GLUCOMMANDER.

    Description of Event or Problem · 1

    GLUCOMMANDER EXPERIENCED AN INTERRUPTION IN THE FLOW OF DATA FROM AN EXTERNAL GLUCOSE DATA SOURCE FOR A BRIEF PERIOD OF TIME. ONCE CONNECTION WAS RE-ESTABLISHED, DATA ANOMALIES WERE OBSERVED. BEFORE THE ANOMALIES WERE CORRECTED, DOSE RECOMMENDATIONS WERE GENERATED FOR SIX (6) PATIENTS. THE ANOMALIES HAD NO IMPACT ON THE APPROPRIATENESS OF THE DOSE RECOMMENDATIONS; THEREFORE, THERE WAS NO RISK TO THESE PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559745 GLUCOMMANDER PREDECTIVE PULMONARY FUNCTION NDC GLYTEC, LLC. 3.4.2.2 00860057000305

    Patients

    Seq Age Sex Outcome Treatment
    1