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

Device Problem Failure to Read Input Signal (1581)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device 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) 2017, the reporter contacted animas alleging a button/keypad (tactile changes/unresponsive) issue.It was reported that the ok button of the keypad was under responsive to user presses.There is no indication that the product issue caused or contributed to an adverse event.This complaint is being reported because the issue has the ability to result in inadvertent or incorrect insulin delivery or the inability to use the pump.

Manufacturer Narrative

Device evaluation: the device has been returned and evaluated by product analysis on 01-feb-2018 with the following findings: all of the keypad buttons were found to be responsive.Moisture was found in the battery compartment.The battery compartment was found to be cracked.

• 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: 7156284
• MDR Text Key: 96115829
• Report Number: 2531779-2017-29500
• Device Sequence Number: 1
• Product Code: OYC
• 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,foreign
• Type of Report: Initial,Followup
• Report Date: 12/08/2017

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: 01/30/2018
• Was the Report Sent to FDA?: Yes
• Device Age: 24 MO
• Initial Date Manufacturer Received: 12/08/2017
• Initial Date FDA Received: 12/30/2017
• Supplement Dates Manufacturer Received: 12/08/2017
• Supplement Dates FDA Received: 02/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/24/2015
• 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: 11 YR