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

Model Number 9500-45

Device Problems Retraction Problem (1536); Firing Problem (4011)

Patient Problem Insufficient Information (4580)

Event Date 10/03/2021

Event Type  malfunction  

Event Description

The needle in the cgm applicator did not retract correctly and would not release.Fda safety report id# (b)(4).

• Brand Name: CGM SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 12583854
• MDR Text Key: 275374880
• Report Number: MW5104430
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000255
• UDI-Public: (01)00386270000255
• 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: 10/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2022
• Device Model Number: 9500-45
• Device Lot Number: 7291479
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1