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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 MT20649-2
Device Problem No Audible Alarm (1019)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/13/2019
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 was provided for evaluation. The complaint confirmation of 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 it passed. The receiver was charged and rebooted. The log was downloaded and reviewed finding no errors related to the complaint. A functional test was performed and the audio test failed due to no audio. A communication tool audio/vibration test was performed, the audio test failed due to no audio and the vibration test passed. A "try it" audio/vibration manual test was performed, the audio test failed due to no audio and the vibration test passed. The receiver case was opened for an internal visual inspection and it passed. A speaker audio intermittent test was performed and the test failed due to no audio. The speaker resistance was measured and it was high. The allegation was confirmed. The root cause was determined to be a defective speaker.
 
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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
kipp durbin
6340 sequence drive
san diego, CA 92121
8582000200
MDR Report Key8413475
MDR Text Key138565583
Report Number3004753838-2019-25184
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
PMA/PMN Number
P120005
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Type of Report Initial,Followup
Report Date 03/12/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMT20649-2
Device Catalogue NumberSTR-GL-102
Device Lot Number5222416
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/06/2019
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/24/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/05/2016
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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