BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3821546 · Received May 20, 2014

    Report

    Report Number
    3004753838-2014-08224
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    February 27, 2014
    Report Date
    February 27, 2014
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PATIENT'S FATHER CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 TO REPORT A BROKEN USB PORT ON (B)(6) 2014. PATIENT'S FATHER ALSO REPORTED THE PATIENT WAS HOSPITALIZED FOR HYPOGLYCEMIA AND RELATED CONDITIONS. THERE WAS NO INFORMATION REGARDING THE INVOLVEMENT OF THE DEXCOM CGM SYSTEM. DEXCOM HAS ISSUED AN RGA FOR PATIENT TO RETURN THE DEVICE TO BE INVESTIGATED.

    Description of Event or Problem · 1

    PATIENT'S FATHER CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 TO REPORT THAT THE PATIENT WAS HOSPITALIZED FOR HYPOGLYCEMIA AND RELATED CONDITIONS ON (B)(6) 2014. THERE WAS NO INFORMATION REGARDING THE INVOLVEMENT OF THE DEXCOM CONTINUOUS GLUCOSE MONITORING (CGM) SYSTEM. DEXCOM HAS ISSUED AN RGA FOR PATIENT TO RETURN THE DEVICE TO BE INVESTIGATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300372 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. MT20649 5053628

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Other