MAUDE Adverse Event Report: Dexcom, Inc. Dexcom G7 GSS; Integrated Continuous Glucose Monitoring System, Factory Calibrated

Model Number	STP-AT-013
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
I had two (2) dexcom g7 glucose sensor fail in a row and could not get a blood glucose reading to deliver my insulin.Both sensors are from the same lot.I am tired of having sensor after sensor fail, dexcom product quality is dangerously poor.Dexcom put my life in danger when shipping faulty product.This is not a first time failure, on average one out of every four sensors has failed for me.The fact that the company replaces them is not a sufficient remedy.| udi: (b)(4) (dexcom g7 gss (161) integrated continuous glucose monitoring system, factory calibrated).This reports captures dexcom g7 #1.Annex a: 1516.Annex e: 4582.Annex g: 510.Annex f: 2199.Reference report mw6001786.

• Brand Name: Dexcom G7 GSS
• Common Device Name: Integrated Continuous Glucose Monitoring System, Factory Calibrated
• Manufacturer (Section D): Dexcom, Inc.
• MDR Report Key: 50567865
• Report Number: MW6001784
• Device Sequence Number: 21319035
• Product Code: QBJ
• UDI-Device Identifier: 00386270004116
• UDI-Public: 00386270004116
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 08/26/2026

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
• Device Model Number: STP-AT-013
• Device Lot Number: 1825270009
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/02/2026
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Unknown