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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 MT24078
Medical Device Problem Code Wireless Communication Problem (3283)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 01/23/2026
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).
 
Event or Problem Description
It was reported that "signal loss" occurred.No product or data was provided for investigation.The allegation and the probable cause cannot be determined.No injury or medical intervention was reported.
 
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Brand Name
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
Common Device Name
CONTINUOUS GLUCOSE MONITOR
Manufacturer (Section D)
DEXCOM, INC.
6340 sequence dr.
san diego CA 92121
Manufacturer Contact
jaime chavez
6340 sequence dr.
san diego, CA 92121
8582000200
MDR Report Key24594767
Report Number3004753838-2026-111698
Device Sequence Number13120425
Product Code QBJ
UDI-Device Identifier00386270000583
UDI-Public(01)00386270000583(10)P10177750
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
DEN170088
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) 03/13/2026
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 Model NumberMT24078
Device Catalogue NumberSTK-OM-001
Device Lot NumberP10177750
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 02/22/2026
Initial Report FDA Received Date03/13/2026
Was Device Evaluated by Manufacturer? (Y/N) No
Date Device Manufactured10/08/2020
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 Age11 YR
Patient SexMale
Patient Weight45 KG
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