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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-PNK
Device Problem Overheating of Device (1437)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/31/2017
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 failed. A charge of the unit was attempted and it failed to charge and boot. The receiver was opened for interior inspection and passed with no moisture damage. A finding related to the complaint in troubleshooting was verified as defective rx main pcba u5. The complaint was confirmed for receiver overheating due to defective receiver pcba u5 (getting hot). The root cause was determined to be a defective receiver main pcba u5.
 
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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 Key6671979
MDR Text Key78578166
Report Number3004753838-2017-50575
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
Type of Report Initial,Followup
Report Date 05/31/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/27/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMT22495-PNK
Device Catalogue NumberSTK-DR-PNK
Device Lot Number5220685
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/15/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/20/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/27/2016
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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