BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONOTORING SYTEM

    MDR report key: 3770824 · Received April 24, 2014

    Report

    Report Number
    3004753838-2014-05480
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Report Date
    March 29, 2014
    Manufacturer
    DEXCOM, INC
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 TO REPORT THAT PATIENT HAD A BROKEN SENSOR WIRE AND A BROKEN CASE. PATIENT DID NOT SPECIFY WHEN THIS EVENT OCCURRED. DEXCOM TECHNICAL SUPPORT MADE SEVERAL ATTEMPTS TO FOLLOW UP ON THIS INCIDENT WITH THE PATIENT, BUT PATIENT NEVER RESPONDED. NO MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248435 G4 PLATINUM CONTINUOUS GLUCOSE MONOTORING SYTEM MDS MDS DEXCOM, INC 9500-27 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other