MAUDE Adverse Event Report: DEXCOM G4 CONTINUOUS GLUCOSE MONITOR

Model Number 9500-26

Device Problem Insufficient Information (3190)

Patient Problems Rash (2033); Discharge (2225); Impaired Healing (2378); Reaction (2414)

Event Type  Injury  

Event Description

Type 1 diabetic child uses dexcom g4.Adhesive from device leaves rash/wound that oozes and will not heal without prescription strength steriod we obtained from her pediatrician.She has been using this device for over a year and has been having this extreme reaction for the last 6 months.

• Brand Name: G4 CONTINUOUS GLUCOSE MONITOR
• Type of Device: G4 CONTINUOUS GLUCOSE MONITOR
• Manufacturer (Section D): DEXCOM
• MDR Report Key: 5347261
• MDR Text Key: 35242321
• Report Number: MW5058894
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 01/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 08/08/2016
• Device Model Number: 9500-26
• Device Lot Number: 5203002
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 6 YR
• Patient Weight: 28