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

Device Problems Image Display Error/Artifact (1304); Structural Problem (2506)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The pump was returned for investigation and device evaluation was completed by product analysis on 12/12/2016 with the following findings.Bumper/grip pads are intact and undamaged.Keypad cover lifted at ok button; all buttons responsive during investigation.Removed cover; no contamination under contacts.Display is dim/fading (pink).Crack between case seal and keypad cover; crack between case seal and display lens corner.Battery compartment crack at case seal below the bumper.(b)(6).

Event Description

There was no adverse event associated with this complaint.The pump was returned for product analysis investigation and the evaluation revealed a cracked compartment and dim display.This report is made based on the results of an investigation completed on (b)(6) 2016.

• 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: 6228637
• MDR Text Key: 64429915
• Report Number: 2531779-2017-00465
• 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: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2017
• 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: 11/11/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 35 MO
• Date Manufacturer Received: 12/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/07/2014
• 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