MAUDE Adverse Event Report: DEXCOM CGM G5 DEXCOM CGM G5; CONTINUOUS GLUCOSE MONITOR SYSTEM

Model Number G5

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Information (3190)

Event Date 04/06/2017

Event Type  malfunction  

Event Description

Dexcom g5 inaccuracy over 24 hour period.

• Brand Name: DEXCOM CGM G5
• Type of Device: CONTINUOUS GLUCOSE MONITOR SYSTEM
• Manufacturer (Section D): DEXCOM CGM G5
• MDR Report Key: 6480431
• MDR Text Key: 72550585
• Report Number: MW5069011
• Device Sequence Number: 1
• Product Code: MDS
• 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: 04/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2017
• Device Model Number: G5
• Device Lot Number: 5219952
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: OTC MEDS: N/A; RX MEDS: NOVOLOG INSULIN.
• Patient Age: 52 YR
• Patient Weight: 61