BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLUCOMMANDER, G+

    MDR report key: 3101446 · Received April 30, 2013

    Report

    Report Number
    3005853093-2013-00001
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    April 26, 2013
    Report Date
    April 30, 2013
    Manufacturer
    GLYTEC, LLC
    Product Code
    NDC
    PMA / PMN Number
    K101344
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REMOTELY CHECKED BY GLYTEC TECHNICAL SUPPORT AND NO MALFUNCTION WAS OBSERVED. IT WAS SUBSEQUENTLY COMMUNICATED TO GLYTEC TECHNICAL SUPPORT THAT THE ALLEGED PROBLEM INVOLVED ONLY ONE UNIT IN THE HOSPITAL (DEVICE HAS BEEN INSTALLED IN (B)(4) UNITS OF HOSPITAL). AFTER RETRYING ACCESS WITH THE RN, THE DEVICE FUNCTIONED PROPERLY. TECHNICAL SUPPORT QUERIED IF THE CUSTOMER'S LOCAL IT HELP DESK HAD BEEN ADVISED OF THE PROBLEM AS IT WAS OCCURRING ON JUST ONE UNIT INDICATING A CUSTOMER HARDWARE PROBLEM.

    Description of Event or Problem · 1

    A HEALTH CARE PROFESSIONAL REPORTED DIFFICULTY OPERATING THE DEVICE AND ALLEGED A DEVICE MALFUNCTION. THE RN DESCRIBES A NUMBER OF ISSUES INCLUDING THE DEVICE IN ICU RED RECEIVING ALARMS FROM ALL OVER THE HOSPITAL AND SCREEN FREEZING STATING THIS IS PLACING PTS AT RISK DUE TO THE FACT THE RN IS NOT BEING NOTIFIED WHEN THE BG IS DUE. THE RN CITES FRUSTRATION WITH THE HOSPITAL MANAGEMENT ALLOWING USE OF THIS PRODUCT STATING IT IS A COMMON PROBLEM WITH OTHER DEVICES AT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188099 GLUCOMMANDER, G+ CLUCOMMANDER, G+ NDC GLYTEC, LLC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other