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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 MT22495
Device Problem Unexpected Shutdown (4019)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/16/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Dexcom was made aware on (b)(4) 2019 that on (b)(6) 2019 the receiver ceased to function. No additional event or patient information is available. No product or data was provided for evaluation. The confirmation of the complaint is undetermined. The probable cause could not be determined.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the receiver ceased to function. The receiver was returned for evaluation. An external visual inspection was performed and passed. A receiver charge and boot was performed and passed. A functional test was performed and passed relevant testing. The log was downloaded and reviewed finding no errors related to the complaint. The receiver case was opened, and an internal visual inspection was performed and passed. Confirmation of the complaint was not confirmed. No injury or medical intervention was reported.
 
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Brand NameDEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
Type of DeviceCONTINUOUS GLUCOSE MONITOR
Manufacturer (Section D)
DEXCOM, INC.
6340 sequence dr.
san diego CA 92121
Manufacturer Contact
kipp durbin
6340 sequence dr.
san diego, CA 92121
8582000200
MDR Report Key8355799
MDR Text Key137168386
Report Number3004753838-2019-020008
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 02/20/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/20/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMT22495
Device Catalogue NumberSTR-DR-001
Device Lot Number5243224
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/20/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/04/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/12/2018
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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