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

Device Problems No Display/Image (1183); Moisture Damage (1405); Structural Problem (2506)

Patient Problem No Consequences Or Impact To Patient (2199)

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 display (damaged w/ moisture) issue.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: 12/27/2016.Device evaluation: the device has been returned and evaluated by product analysis on 12/02/2016 with the following findings: during investigation, the pump was returned with moisture visible through the display lens and with scratches on the display lens.A leak test failed due to a crack in the battery compartment.The pump was opened and there was moisture observed throughout the pump casing.The battery compartment was found to be cracked.A leak test was not found at this site.

• 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: 6093794
• MDR Text Key: 59979146
• Report Number: 2531779-2016-31165
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 10840406100068
• UDI-Public: 0110840406100068
• 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: 10/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 11/11/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 18 MO
• Initial Date Manufacturer Received: 10/21/2016
• Initial Date FDA Received: 11/10/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2015
• 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
• Patient Age: 21 YR