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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 MT22608
Medical Device Problem Code Wireless Communication Problem (3283)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 04/13/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).
 
Event or Problem Description
Dexcom was made aware on (b)(4) 2018, that on (b)(6) 2018, a loss of connection occurred.No product or data was provided for evaluation.Confirmation of the issue was undetermined.The probable cause could not be determined.No additional event or patient information is available.
 
Additional Manufacturer Narrative
(b)(4).
 
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Brand Name
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
Common Device Name
CONTINUOUS GLUCOSE MONITOR
Manufacturer (Section D)
DEXCOM, INC.
6340 sequence dr.
san diego CA 92121
MDR Report Key7511393
Report Number3004753838-2018-051435
Device Sequence Number11206472
Product Code MDS
UDI-Device Identifier10386270000184
UDI-Public10386270000184
Combination Product (Y/N)N
Initial Reporter StateCO
Initial Reporter CountryUS
PMA/510(K) Number
P120005
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source consumer
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 04/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Lay User/Patient
Device Model NumberMT22608
Device Catalogue NumberSTK-PR-001
Device Lot Number5224946
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 04/14/2018
Supplement Date Received by Manufacturer05/15/2018
Initial Report FDA Received Date05/14/2018
Supplement Report FDA Received Date05/19/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age6 YR
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