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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 MT20649-1
Device Problem Improper Device Output (2953)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/27/2015
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Distributor contacted dexcom on behalf of the patient on (b)(6) 2015 to claim no audio output on (b)(6) 2015.There was no report any injury or medical intervention.No additional event or patient information is available.
 
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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 Key5369410
MDR Text Key36427983
Report Number3004753838-2016-25025
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
P120005
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation Other
Type of Report Initial
Report Date 12/23/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/15/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberMT20649-1
Device Catalogue NumberSTK-GL-013
Device Lot Number5203298
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received12/23/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/09/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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