BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 5680588 · Received May 25, 2016

    Report

    Report Number
    3004753838-2016-90438
    Event Type
    Malfunction
    Date Received
    May 25, 2016
    Date of Event
    April 10, 2016
    Report Date
    February 12, 2025
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    UDI-DI
    00386270000088
    PMA / PMN Number
    P120005
    Removal / Correction Number
    3004753838-02/29/16-001C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4). B5: B5: DESCRIBE EVENT OR PROBLEM - CORRECTION. G7: TYPE OF REPORT. H2 TYPE OF FOLLOW UP - CORRECTION. THIS SUPPLEMENTAL MDR WITH FOLLOW-UP #01 IS BEING SUBMITTED TO CORRECT THE G7 TYPE OF REPORT FOLLOW-UP NUMBER, WHICH WAS PREVIOUSLY SUBMITTED AS FOLLOW-UP #02 ON WED SEP 28 08:30:20 EDT 2016 WITH MFR# 3004753838-2016-90438. THE ACK3 WAS RECEIVED ON WED SEP 28 08:30:20 EDT 2016 WITH COREID: (B)(4).

    Description of Event or Problem · 0

    THIS SUPPLEMENTAL MDR WITH FOLLOW-UP #01 IS BEING SUBMITTED TO CORRECT THE G7 TYPE OF REPORT FOLLOW-UP NUMBER, WHICH WAS PREVIOUSLY SUBMITTED AS FOLLOW-UP #02.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM ON 04/28/2016 TO CLAIM NO AUDIO OUTPUT ON (B)(6) 2016. THERE WAS NO REPORT OF ANY INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333171 DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. MT20649-PNK 5195035 00386270000088

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female