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

Device Problem Inaccurate Delivery (2339)

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

The reporter contacted animas on (b)(6) 2016 alleging the pump demonstrated an issue with inaccurate delivery, that the "base flow blocked after several hours." animas customer technical support made several attempts to follow up with the reported for more information regarding this alleged issue, but the reporter did not respond to those attempts.There was no reported adverse physical event associated with this complaint.This complaint is being reported because the alleged remained unresolved.

Manufacturer Narrative

Follow up #1 submitted: 04/22/2016.Due diligence follow up information revealed that the complaint did not involve an "inaccurate delivery issue" with the pump.The reporter confirmed that the complaint was of a different nature that will be reported on a separate individual report.

Manufacturer Narrative

Follow up #2 submitted 04/22/2016.Due diligence follow up revealed that the user alleged random call service alarm 064 or occlusion alarms with infusion set tubing/site.Instructions were followed for insertion of the infusion set.This complaint is being reported because the alleged occlusion issue remained unresolved.

Manufacturer Narrative

Follow-up #1: date of submission 05/26/2016.Review of the black box data revealed the last basal delivery was on (b)(6) 2016@6:51pm.Multiple basal delivery interruption caused by power interruptions are observed from (b)(6) 2016@7:49pm.From (b)(6) 2016@2:42pm.The basal program was manually cleared and the pump was running on a 0.00 unit per hour empty basal program for 16 days from (b)(6) 2016@08:35am.The total daily doses add up correctly and reflect the programmed basal rate target.No battery cap was returned.The battery compartment was undamaged and a test cap is able to fit to maintain electrical connection."ez-prime" steps were performed; the pump reflected 24 units after 24 hours on 1.0 unit per hour duration test.No delivery interruptions occurred during the investigation.The product performed within the required specifications.Investigation did not duplicate the "inaccurate delivery" complaint.

• 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: 5596480
• MDR Text Key: 43872208
• Report Number: 2531779-2016-08265
• 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,Followup,Followup
• Report Date: 03/24/2016

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: 04/26/2016
• Was the Report Sent to FDA?: Yes
• Device Age: 10 MO
• Initial Date Manufacturer Received: 03/24/2016
• Initial Date FDA Received: 04/21/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 04/22/2016; 04/22/2016; 05/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2015
• 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