• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number MT20649-2
Device Problem Unexpected Shutdown (4019)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/17/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Dexcom was made aware on 02/25/2019 that on (b)(6) 2019 the receiver shutdown unexpectedly. No additional event or patient information is available. No product was provided for evaluation. The complaint confirmation of the receiver ceasing to function could not be determined. A root cause could not be determined.
 
Manufacturer Narrative
(b)(4). Describe event or problem -correction "dexcom was made aware on 02/25/2019 that on (b)(6)2019 the receiver shutdown unexpectedly. The complaint confirmation of the receiver ceasing to function could not be determined. ".
 
Event Description
Dexcom was made aware on 02/25/2019 that on (b)(4)2019 the receiver initialized without manual restart. The complaint confirmation of initializing screen without manual restart could not be determined.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
Type of DeviceCONTINUOUS GLUCOSE MONITOR
Manufacturer (Section D)
DEXCOM, INC.
6340 sequence drive
san diego, ca CA 92121
Manufacturer (Section G)
DEXCOM, INC.
6340 sequence drive
san diego, ca CA 92121
Manufacturer Contact
ashley spoto
6340 sequence drive
san diego, ca, CA 92121
8582000200
MDR Report Key8449998
MDR Text Key140154649
Report Number3004753838-2019-29032
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
P120005
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/07/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/25/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMT20649-2
Device Catalogue NumberSTK-GL-117
Device Lot Number5241414
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/23/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-