BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3771650 · Received April 24, 2014

    Report

    Report Number
    3004753838-2014-04496
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    March 30, 2014
    Report Date
    March 31, 2014
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE RETURNED DEVICE CONFIRMED THE REPORTED OF NO VIBRATION. THE ROOT CAUSE WAS DETERMINED TO BE A DEFECTIVE VIBRATE MOTOR.

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 AND CLAIMED THAT ON (B)(6) 2014 PATIENT EXPERIENCED NO AUDIBLE OR VIBRATORY OUTPUT. DEXCOM HAS ISSUED AN RGA FOR PATIENT TO RETURN HER DEVICE TO BE INVESTIGATED. PATIENT DID NOT REPORT ANY INJURY OR MEDICAL INTERVENTION AT THE TIME OF CONTACT WITH DEXCOM TECHNICAL SUPPORT.

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 AND CLAIMED THAT ON (B)(6) 2014 PATIENT EXPERIENCED NO AUDIBLE OR VIBRATORY OUTPUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249953 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. MT20649 5076241

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other