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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 9438-05
Device Problem Wireless Communication Problem (3283)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/26/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Dexcom was made aware on (b)(4) 2018, that on (b)(6) 2018, a loss of connection occurred.No additional event information is available.No product or data was provided for evaluation.Loss of connection could not be determined.The 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 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 Key8191412
MDR Text Key131325485
Report Number3004753838-2018-160896
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeSW
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 11/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number9438-05
Device Catalogue NumberSTT-GL-004
Device Lot Number5236823
Was Device Available for Evaluation? No
Date Manufacturer Received11/28/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/29/2018
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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