MAUDE Adverse Event Report: ANIMAS CORPORATION ANIMAS VIBE; INSULIN INFUSION PUMP

Device Problem Temperature Problem (3022)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The pump has been returned to animas.Evaluation has not yet been completed.When evaluation is complete a supplemental report will be filed.No conclusion can be made at this time.Initial reporter: (b)(6).

Event Description

On (b)(6) 2016, the reporter contacted animas alleging a temperature (temp - no physical damage) issue.It was reported that the battery became so hot that the pump felt burning hot.There was no reported physical damage to the pump.There was no reported bodily injury due to the temperature issue.This complaint is being reported because there is the potential for the user to experience an injury to the skin due to increased pump temperature.

Manufacturer Narrative

Follow-up #1: date of submission 03/21/2017.Device evaluation: the device has been returned and evaluated by product analysis on 02/22/2017 with the following findings: review of the black box data revealed activity from (b)(6) 2016; there is no evidence of voltage drop or excessive battery usage.On investigation, the pump powered on with the returned battery cap securely in place.Electrical current draws were evaluated and found to be within specifications.There was no evidence of contamination inside the battery compartment.The pump was opened for further investigation and did not reveal any evidence of damage, defect or contamination of the pump¿s interior components.Investigation did not confirm nor duplicate the complaint.Unrelated to the original complaint, the battery compartment was noted to be cracked.(b)(4).

• Brand Name: ANIMAS VIBE
• Type of Device: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS CORPORATION; 200 lawrence dr; west chester PA 19380 3428
• Manufacturer (Section G): ANIMAS CORPORATION; 200 lawrence dr; west chester PA 19380 3428
• Manufacturer Contact: karin sargrad ; 200 lawrence dr; west chester, PA 19380-3428 ; 4843561808
• MDR Report Key: 6272711
• MDR Text Key: 65917285
• Report Number: 2531779-2017-01952
• 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: distributor,foreign
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 12/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Other Device ID Number: 1-MCBC-3762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 22 MO
• Date Manufacturer Received: 12/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2015
• 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