MAUDE Adverse Event Report: DEXCOM G4 PLATINUM SENSOR

Model Number STS-GL-041

Device Problem Insufficient Information (3190)

Patient Problems Erythema (1840); Hemorrhage/Bleeding (1888); Itching Sensation (1943); Rash (2033)

Event Date 12/15/2015

Event Type  Injury  

Event Description

My daughter has type 1 diabetes and uses a dexcom g4 continuous glucose sensor.The adhesive for these devices causes a serious rash at the site of the sensor and pump.We change the pump pods every 3 days and the sensors every 7.We have to use barriers underneath both in order to curb the rash, otherwise the itching, redness and bleeding become too much to bear.

• Brand Name: G4 PLATINUM SENSOR
• Type of Device: G4 PLATINUM SENSOR
• Manufacturer (Section D): DEXCOM
• MDR Report Key: 5347260
• MDR Text Key: 35243444
• Report Number: MW5058893
• 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: No Information
• Device Expiration Date: 04/30/2016
• Device Model Number: STS-GL-041
• Device Lot Number: 5201015
• Other Device ID Number: (01)30386270000010
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 5 YR
• Patient Weight: 19