• 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 DEXCOM SHARE SYSTEM MDS

  • 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 DEXCOM SHARE SYSTEM MDS Back to Search Results
Model Number MT22495-BLU
Device Problem Defective Alarm (1014)
Patient Problems Hypoglycemia (1912); Sprain (2083); Concussion (2192); Injury (2348); Neck Pain (2433)
Event Date 05/17/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). Diabetes mellitus is a known cause of hypoglycemia.
 
Event Description
Patient contacted dexcom on (b)(6) 2016 to report that they experienced intermittent audio output and an adverse event on (b)(6) 2016. The patient was in a car wreck due to a low and the receiver's audio not going off. The paramedics treated the low on the scene with glucose tabs and juice boxes. Patient sustained a concussion, whiplash and a sprained wrist. The patient did not go to the hospital. Additionally, the patient tested the receiver's attentive and fixed low alerts and they worked. At the time of contact, the patient was okay. No additional event or patient information was provided. The complaint device was returned for evaluation. The device passed both internal and external visual inspection. There were no data log errors found that related to the complaint. Global receiver functional testing resulted in no failures related to the incident. The device passed the audio test, global communication tool software test and the drop test. The device also passed speaker resistance measurements. The reported fault could not be reproduced. The customer complaint could not be confirmed. A root cause could not be determined.
 
Manufacturer Narrative
(b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM
Type of DeviceMDS
Manufacturer (Section D)
DEXCOM, INC.
6340 sequence drive
san diego CA 92121
Manufacturer (Section G)
DEXCOM, INC.
6340 sequence drive
san diego CA 92121
Manufacturer Contact
kipp durbin
6340 sequence drive
san diego, CA 92121
8582000200
MDR Report Key5731162
MDR Text Key47585973
Report Number3004753838-2016-03458
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P120005
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup
Report Date 05/18/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/16/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMT22495-BLU
Device Catalogue NumberSTK-DR-BLU
Device Lot Number5202781
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/07/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/03/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/30/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction Number3004753838-02/29/16-001C

Patient Treatment Data
Date Received: 06/16/2016 Patient Sequence Number: 1
-
-