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U.S. Department of Health and Human Services

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

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DEXCOM, INC. DEXCOM G4 PLATINUM PEDIATRIC CONTINUOUS GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 9438-06
Device Problems Use of Device Problem (1670); Wireless Communication Problem (3283)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/04/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Dexcom was made aware on (b)(4) 2018, that on (b)(6) 2018, a loss of connection occurred. It was determined that loss of connection was related to the mobile application. No data was provided for evaluation. Confirmation of the issue was undetermined. The root cause could not be determined. Labeling indicates that the dexcom cgm application is only compatible for select devices and operating systems. No additional event or patient information is available.
 
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Brand NameDEXCOM G4 PLATINUM PEDIATRIC 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 Key7656136
MDR Text Key113022296
Report Number3004753838-2018-71819
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeGM
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
Report Date 06/05/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/02/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9438-06
Device Catalogue NumberSTT-GF-004
Device Lot Number5226624
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/05/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/27/2017
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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