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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 Unexpected Shutdown (4019)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/10/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Dexcom was made aware on 02/11/2019, that on (b)(6) 2019, an unexpected receiver shutdown occured.No additional event or patient information is available.No product or data was provided for evaluation.The complaint confirmation of the reported unexpected receiver shutdown could not be determined.A root cause could not be determined.
 
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Brand Name
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
Type of Device
CONTINUOUS 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 Key8406394
MDR Text Key138403278
Report Number3004753838-2019-24623
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 Other
Type of Report Initial
Report Date 03/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/09/2019
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberMT20649-1
Device Catalogue NumberSTK-GL-010
Device Lot Number5235216
Was Device Available for Evaluation? Yes
Date Manufacturer Received02/11/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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 Age76 YR
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