MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G7 SENSOR; SENSOR, GLUCOSE, INVASIVE

Device Problems Break (1069); Difficult to Insert (1316); Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

Dexcom g7 had multiple issues with past 3 devices, one device way off even after calibrating, second either short needle or needle broke inside my arm have to follow up with dr.Third unit failed to insert needle into arm got tangled inside device, leaving me with no device to check my sugar.Reference reports: mw5116794, mw5116795.

• Brand Name: DEXCOM G7 SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 16769330
• MDR Text Key: 313726782
• Report Number: MW5116796
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: "MEDROMIN"
• Patient Outcome(s): Disability
• Patient Age: 37 YR
• Patient Sex: Male
• Patient Weight: 113 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White