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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G6 PROFESSIONAL SYSTEM; CONTINUOUS GLUCOSE MONITOR
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DEXCOM, INC. DEXCOM G6 PROFESSIONAL SYSTEM; CONTINUOUS GLUCOSE MONITOR Back to Search Results
Catalog Number STK-RD-001
Medical Device Problem Code Inappropriate or Unexpected Reset (2959)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 04/30/2025
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).
 
Event or Problem Description
It was reported that a receiver reinitialization occurred.No product or data was provided for evaluation.The allegation and a probable cause could not be determined.No injury or medical intervention was reported.
 
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Brand Name
DEXCOM G6 PROFESSIONAL SYSTEM
Common Device Name
CONTINUOUS GLUCOSE MONITOR
Manufacturer (Section D)
DEXCOM, INC.
6340 sequence dr.
san diego CA 92121
Manufacturer Contact
ashley spoto
6340 sequence dr.
san diego, CA 92121
8582000200
MDR Report Key22096568
Report Number3004753838-2025-130486
Device Sequence Number8022201
Product Code QII
UDI-Device Identifier00386270001061
UDI-Public00386270001061
Combination Product (Y/N)N
Initial Reporter StateMT
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source Consumer
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 05/28/2025
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Lay User/Patient
Device Catalogue NumberSTK-RD-001
Was Device Available for Evaluation? Yes
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 04/30/2025
Initial Report FDA Received Date05/28/2025
Was Device Evaluated by Manufacturer? (Y/N) No
Is the Device Labeled for Single Use? (Y/N) No
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Initial
Patient Sequence Number1
Patient SexMale
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