MAUDE Adverse Event Report: DEXCOM INC. ANIMAS VIBE OYC

Device Problem Insufficient Information (3190)

Patient Problem Discomfort (2330)

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to animas. If the device is returned, an evaluation shall be completed and a supplemental report will be filed. No conclusion can be made at this time.

Event Description

On (b)(6) 2016 the reporter contacted animas alleging an irritation/discomfort issue. There is no indication that the product issue caused or contributed to an adverse event. This complaint is being reported because the issue remained unresolved at the time of troubleshooting.

• 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: 5588281
• MDR Text Key: 43798879
• Report Number: 2531779-2016-08140
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/01/2016

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: No Information
• Date Manufacturer Received: 04/01/2016
• 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: Unkown