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U.S. Department of Health and Human Services

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

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DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM Back to Search Results
Model Number MT22495-BLU
Device Problems Overheating of Device (1437); Use of Device Problem (1670)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/23/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Dexcom was made aware on (b)(6) 2017 that on (b)(6) 2017, the receiver was overheating. No additional event or patient information is available. The complaint device was returned for evaluation. The device was visually inspected and no defect was found. The receiver would not take a charge or boot-up. The receiver case was opened for further evaluation. An interior inspection found moisture damage, pcba contamination, and the moisture detection sticker activated. Due to moisture damage, the complaint of overheating receiver could not be confirmed. The root cause could not be determined. It was reported that the receiver was exposed to moisture. Labeling indicates: keep the receiver dry. Do not spill fluids on it or drop it into fluids.
 
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Brand NameDEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM
Type of DeviceCONTINUOUS GLUCOSE MONITOR
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 Key6570669
MDR Text Key75327823
Report Number3004753838-2017-26491
Device Sequence Number1
Product Code MDS
UDI-Device Identifier30386270000171
UDI-Public(01)30386270000171(241)STR-DR-BLU(10)5222067
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
Type of Report Initial
Report Date 04/23/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/16/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMT22495-BLU
Device Catalogue NumberSTR-DR-BLU
Device Lot Number5222067
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/12/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/23/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/15/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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