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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
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DEXCOM, INC. DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 9500-45
Device Problem Retraction Problem (1536)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/28/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Dexcom was made aware on (b)(4) 2018 that on (b)(6) 2018, a needle retraction issue occurred.The sensor was inserted into the abdomen on (b)(6) 2018.No product or data was provided for evaluation.Confirmation of the problem and probable cause could not be determined.No additional event or patient information is available.
 
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Brand Name
DEXCOM G6 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 Key7674820
MDR Text Key113638942
Report Number3004753838-2018-074977
Device Sequence Number1
Product Code MDS
UDI-Device Identifier00386270000255
UDI-Public00386270000255
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P170031
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Other
Type of Report Initial
Report Date 06/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/10/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date12/23/2018
Device Model Number9500-45
Device Catalogue NumberSTS-OR-001
Device Lot Number5238697
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received06/29/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/21/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age23 YR
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