MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

Catalog Number	STS-OM-001
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Codes	Hyperglycemia (1905); Dizziness (2194); Urinary Frequency / Polyuria (2275)
Date of Event	10/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Diabetes mellitus is a known cause of hyperglycemia.
Event or Problem Description
It was reported that an inaccuracy between the continuous glucose monitor (cgm) and the blood glucose (bg) meter occurred.The sensor was inserted into the abdomen on (b)(6) 2025.On 10/27/2025, it was reported that the patient was awakened by an alarm on her cgm indicating an urgent low glucose alert without a specific value.She felt dizzy and, without checking her blood glucose via fingerstick , she drank orange juice before returning to sleep.Later, she was again awakened by another urgent low alarm and consumed more orange juice.Despite this, she continued to experience frequent urination and noticed that her cgm still displayed an urgent low alert.She then checked her blood glucose with a fingerstick, which read 587 mg/dl, while the cgm continued to show urgent low with no numeric value.The patient removed her cgm sensor, administered 10 units of humalog by injection, and was transported to the hospital by her sister.At the emergency room (er), her blood glucose was 562 mg/dl.She was treated with insulin drip and received iv fluids with magnesium, potassium, sodium, and saline.She remained hospitalized overnight.At the time of discharge, her blood glucose was 91 mg/dl, and she reported feeling much better.Data was evaluated and the allegation was undetermined.The probable cause could not be determined via data.The reported glucose values fall within the d zone of the parkes error grid.At the er, there was not a complete set of reported glucose values available to search within the parkes error grid calculator.The data investigation did not find blood glucose calibration values to compare to cgm values during the reported sensor session or the calibrations during the reported sensor session were in accurate range per device specifications.No additional patient or event information is available.
Additional Manufacturer Narrative
B5 describe event or problem - additional.H2 additional information.H6 investigation conclusion - additional.
Event or Problem Description
Subsequent to the initial mdr, additional information became available.It was reported that an inaccuracy between the continuous glucose monitor (cgm) and the blood glucose (bg) meter occurred.It was indicated that the patient rubbed/bumped/laid on the transmitter, which is misuse of the device.The sensor was inserted into the abdomen on (b)(6) 2025.On 10/27/2025, it was reported that the patient was awakened by an alarm on her cgm indicating an urgent low glucose alert without a specific value.She felt dizzy and, without checking her blood glucose via fingerstick, she drank orange juice before returning to sleep.Later, she was again awakened by another urgent low alarm and consumed more orange juice.Despite this, she continued to experience frequent urination and noticed that her cgm still displayed an urgent low alert.She then checked her blood glucose with a fingerstick, which read 587 mg/dl, while the cgm continued to show urgent low with no numeric value.The patient removed her cgm sensor, administered 10 units of humalog by injection, and was transported to the hospital by her sister.At the emergency room (er), her blood glucose was 562 mg/dl.She was treated with insulin drip and received iv fluids with magnesium, potassium, sodium, and saline.She remained hospitalized overnight.At the time of discharge, her blood glucose was 91 mg/dl, and she reported feeling much better.Data was evaluated and the allegation was undetermined.The probable cause could not be determined via data.The reported glucose values fall within the d zone of the parkes error grid.At the er, there was not a complete set of reported glucose values available to search within the parkes error grid calculator.The data investigation did not find blood glucose calibration values to compare to cgm values during the reported sensor session or the calibrations during the reported sensor session were in accurate range per device specifications.No additional patient or event information is available.

• 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: ashley spoto ; 6340 sequence dr.; san diego, CA 92121 ; 8582000200
• MDR Report Key: 23513930
• Report Number: 3004753838-2025-315614
• Device Sequence Number: 9877292
• Product Code: QBJ
• UDI-Device Identifier: 80386270000251
• UDI-Public: (01)80386270000251
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: DEN170088
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: STS-OM-001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/30/2025
• Supplement Date Received by Manufacturer: 12/02/2025
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TANDEM TSLIM PUMP
• Outcome Attributed to Adverse Event: Other
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 61 KG