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

Device Problem Data Problem (3196)

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 history/settings (history/settings issue) issue; bolus delivery not recording in history.This complaint is being reported because an issue with the pump not performing as intended with regards to the history or the settings 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 08/09/2016.Device evaluation: the device has been returned and evaluated by product analysis on 07/20/2016 with the following findings: review of the black box data revealed the last bolus delivery was recorded on (b)(6) 2016 at 12:41 pm.The total daily dose amounts added up to correctly reflect the user¿s programmed bolus delivery target.The bolus history revealed two manually-cancelled boluses on (b)(6) 2016.On testing, ez-prime steps were correctly performed.Delivery accuracy testing showed the pump was delivering accurately and boluses were recorded at the correct time and in the correct order in the bolus history.Investigation did not duplicate the ¿bolus not recorded¿ complaint.Unrelated to the original complaint the battery compartment was noted 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: 5737908
• MDR Text Key: 47837197
• Report Number: 2531779-2016-12481
• 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,foreign
• Type of Report: Initial,Followup
• Report Date: 06/03/2016

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2016
• Was the Report Sent to FDA?: Yes
• Device Age: 12 MO
• Initial Date Manufacturer Received: 06/03/2016
• Initial Date FDA Received: 06/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2015
• 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