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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 07/23/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that unexpected receiver shutdown occurred. No product or data was provided for evaluation. Confirmation of the allegation and a probable cause could not be determined. No injury or medical intervention was reported.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The product was evaluated. An external visual inspection was performed and passed. A receiver charge and boot test was performed and failed due to rx unit not booting up and\or communicating. An internal visual inspection was performed and failed due to moisture damage. Pictures were taken. The log was not downloaded for review due to rx unit not booting up and\or communicating. Confirmation of the allegation and a probable cause could not be determined. 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
ying chen
6340 sequence dr.
san diego, CA 92121
8582000200
MDR Report Key8915135
MDR Text Key155050692
Report Number3004753838-2019-061186
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 09/25/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/21/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMT22495
Device Catalogue NumberSTK-DR-001
Device Lot Number5253445
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/26/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/11/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/16/2019
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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