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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

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DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number MT20649-2
Device Problem Overheating of Device (1437)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/31/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Dexcom was made aware on (b)(4) 2017, that on (b)(6) 2017, the receiver was overheating. No additional event or patient information is available. The device has been received for evaluation.   a follow-up report will be submitted once the evaluation is complete.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The complaint receiver device was returned for evaluation. An external visual inspection was performed it passed. The receiver failed to charge and reboot. Receiver log was not available for download. Functional testing could not be performed. The receiver case was opened for further evaluation. An interior inspection found the moisture detection sticker activated. Due to moisture damage, the reported event of an overheating receiver was confirmed. The root cause was determined to be moisture damage.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The complaint device was returned for evaluation. The device was visually inspected and no defect was found. The receiver was charged and would not boot. Functional testing and data download were unable to be performed. The receiver case was opened for further evaluation. A visual interior inspection was performed and found that the moisture detection sticker was activated. The complaint confirmation was unable to be determined. A root cause could not be determined.
 
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Brand NameDEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING 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 Key6807348
MDR Text Key83138838
Report Number3004753838-2017-67847
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
P120005
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 07/31/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/21/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMT20649-2
Device Catalogue NumberSTK-GL-113
Device Lot Number5219511
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/09/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/24/2017
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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