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

Device Problems Moisture Damage (1405); Device Stops Intermittently (1599)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The pump 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. No conclusions can be made at this time.

Event Description

On (b)(6) 2016, the reporter contacted animas, alleging a power (moisture ingress) issue. The user alleged intermittent power issue and reported that there was moisture behind the display. This complaint is being reported because the issue may impact the user's ability to read some or all of the information on the screen which may result in over or under delivery. There was no indication that the product caused or contributed to an adverse event.

Manufacturer Narrative

Follow-up #1: date of submission 06/24/2016 device evaluation: the device has been returned and evaluated by product analysis on 06/14/2016 with the following findings: the pump's black box showed pump reboot events associated with a cartridge change on (b)(6) 2016. There were additional pump reboot events relating to expected replace battery alarms on (b)(6) 2016. There was evidence of moisture behind display lens. The battery compartment was found to be cracked. The pump case was cracked in the corner of the display area. The pump was exercised with the returned battery cap for 24 hours with no reboot, loss of power or call service alarms duplicated. The alleged issue could not be duplicated. There was additional evidence of moisture on the internal components of the pump.

• 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: 5666330
• MDR Text Key: 45571579
• Report Number: 2531779-2016-10217
• 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,Followup
• Report Date: 05/10/2016

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 05/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Other Device ID Number: 011084040610008221267703516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 10 MO
• Event Location: No Information
• Date Manufacturer Received: 05/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown