MAUDE Adverse Event Report: DEXCOM INC. ANIMAS VIBE; INSULIN INFUSION PUMP

Device Problem Insufficient Information (3190)

Patient Problem Skin Irritation (2076)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2016, the reported contacted animas and alleged that for 2 weeks the patient has had a raised red bumps small pimples on her arm after sensor pod was taken off.Patient is seeking treatment and has a doctor's appointment.Skin reaction from the adhesive may be normal for some patients this complaint is being reported because the patient's condition required medical intervention.

• Brand Name: ANIMAS VIBE
• Type of Device: INSULIN INFUSION PUMP
• 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: 5834634
• MDR Text Key: 50805283
• Report Number: 2531779-2016-18172
• 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: 07/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2016
• 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 07/06/2016
• 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: 11 YR