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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 MT20649-3
Device Problem Inappropriate or Unexpected Reset (2959)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/20/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the device displayed new sensor during a sensor session. 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
It was reported that the device displayed new sensor during a sensor session. The product was evaluated. An exterior visual inspection was performed and passed. Charge and boot testing was performed and failed due to the receiver not turning on. Receiver functional test was performed and failed due to receiver not turning on. An interior visual inspection was performed and passed. Using a known good battery, the receiver log was downloaded and reviewed, finding no errors related to the complaint. Confirmation of the allegation could not be determined. A probable cause could not be determined as the allegation was not found. 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
ashley spoto
6340 sequence dr.
san diego, CA 92121
8582000200
MDR Report Key9632371
MDR Text Key176420019
Report Number3004753838-2020-008028
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 distributor,foreign
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/23/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/27/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMT20649-3
Device Catalogue NumberSTR-JP-001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/14/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/19/2020
Was Device Evaluated by Manufacturer? Yes
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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