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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; MDS

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DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM; MDS Back to Search Results
Model Number MT20649-BLU
Device Problem Device Stops Intermittently (1599)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/16/2015
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Patient contacted dexcom on (b)(6) 2015 to claim intermittent audio output on (b)(6) 2015.There was no report any injury or medical intervention.No additional even or patient information is available.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The complaint device was returned for evaluation.The device was visually inspected and no defect was found.Functional testing was performed and the reported fault could not be reproduced and there was no failure detected.A review of the downloaded receiver log did not find any errors related to the customer complaint.A manual drop test for intermittency was performed and the test passed.The device was determined to be operating within the required specifications without malfunction.The reported event of no audio output was not confirmed.A root cause could not be determined.
 
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Brand Name
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
Type of Device
MDS
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 Key5278084
MDR Text Key33608586
Report Number3004753838-2015-66880
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 Other
Type of Report Initial,Followup
Report Date 11/16/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberMT20649-BLU
Device Catalogue NumberSTR-GL-BLU
Device Lot Number5196994
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/09/2015
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/16/2015
Initial Date FDA Received12/09/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received01/30/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age59 YR
Patient Weight93
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