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

Device Problem Retraction Problem (1536)

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 motor (rewind issue) issue.It was reported that the piston rod was not retracting.There was no indication that the product caused or contributed to an adverse event.This complaint is being reported because the insulin delivery could be affected.

Manufacturer Narrative

Follow-up #1: date of submission 03/09/2017 device evaluation: the device has been returned and evaluated by product analysis on 02/17/2017 with the following findings: a review of the black box and alarm history did not indicate any motor or rewind issues.The pump powered on normally and successfully completed rewind, load, and prime steps.The pump was exercised for 24 hours with no motor or rewind issues occurring.The pump was returned with the piston cap missing, however the piston cap does not interfere with motor or rewind functions.The complaint could not be confirmed or duplicated on investigation.Unrelated to the original complaint, investigation revealed that the display was dim and discolored.(b)(4).

• 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: 6103615
• MDR Text Key: 60295350
• Report Number: 2531779-2016-31378
• 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: distributor,foreign
• 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: 11/15/2016
• Was the Report Sent to FDA?: Yes
• Device Age: 33 MO
• Initial Date Manufacturer Received: 10/21/2016
• Initial Date FDA Received: 11/15/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2014
• 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