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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
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DEXCOM, INC. DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number N/A
Device Problem Display or Visual Feedback Problem (1184)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/30/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Dexcom was made aware on (b)(4) 2018, that on (b)(6) 2018, a screen display frozen occurred.No additional patient or event information is available.No data was provided for evaluation.The complaint confirmation of a screen display frozen could not be determined.A root cause could not be determined.
 
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Brand Name
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
Type of Device
CONTINUOUS GLUCOSE MONITOR
Manufacturer (Section D)
DEXCOM, INC.
6340 sequence dr.
san diego CA 92121
Manufacturer Contact
kipp durbin
6340 sequence dr.
san diego, CA 92121
8582000200
MDR Report Key7226599
MDR Text Key98832017
Report Number3004753838-2018-010340
Device Sequence Number1
Product Code MDS
UDI-Device Identifier00386270000002
UDI-Public00386270000002
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
Report Date 12/30/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/29/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberN/A
Device Catalogue NumberSW10611
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received12/30/2017
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 Age60 YR
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