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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 MT20649-1
Device Problem No Audible Alarm (1019)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/06/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Dexcom was made aware on (b)(4) 2019 that on (b)(6) 2019 the receiver had no audio output. No additional event or patient information is available. No product or data were provided for evaluation. The reported no audio output could not be determined. A root cause could not be determined.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The product was evaluated. The device was visually inspected and passed. The receiver was charged and rebooted. A functional test was performed and it passed. The log was downloaded and reviewed finding no errors related to the complaint. A communication tool audio and vibration test was performed and it passed. "try it" manual tests were performed and passed. The receiver case was opened for an internal visual inspection and it passed. Speaker audio and vibrator intermittent tests were performed and the tests passed. The speaker and vibrator resistance were measured and they measured within specification. The allegation was not confirmed. The root cause could not be determined.
 
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Brand NameDEXCOM G4 PLATINUM 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
ying chen
6340 sequence drive
san diego, CA 92121
8582000200
MDR Report Key8457530
MDR Text Key140159920
Report Number3004753838-2019-29660
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,Followup
Report Date 03/27/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/27/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMT20649-1
Device Catalogue NumberSTK-GL-010
Device Lot Number5233420
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/16/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/24/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/17/2017
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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