MAUDE Adverse Event Report: DEXCOM INC. ANIMAS VIBE; OYC

Device Problem Insufficient Information (3190)

Patient Problems Rash (2033); Skin Irritation (2076)

Event Type  Injury  

Manufacturer Narrative

The device has not been returned to animas for evaluation.If the device is returned, an evaluation shall be completed and a supplemental report will be filed.

Event Description

On (b)(6) 2016, the reporter contacted animas and alleged that about 5 months ago, the patient visited a health care provider seeking treatment for a red and weepy sensor site irritation/rash.The hcp recommended treatment with hydrocortisone cream twice daily.This complaint is being reported as the patient required medical intervention for the issue.

• Brand Name: ANIMAS VIBE
• Type of Device: OYC
• Manufacturer (Section D): DEXCOM INC.; 6340 sequence dr; san diego CA 92121 4356
• Manufacturer (Section G): DEXCOM INC.; 6340 sequence dr; san diego CA 92121 4356
• Manufacturer Contact: 6340 sequence dr; san diego, CA 92121-4356
• MDR Report Key: 5771826
• MDR Text Key: 48831843
• Report Number: 2531779-2016-14788
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• PMA/PMN Number: P130007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 06/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 06/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 7 YR