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 at the time of this report.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, a reporter contacted animas alleging that there was an inaccurate delivery of inuslin.This complaint is being reported because the reported issue was not resolved through troubleshooting.There was no allegation of an adverse event associated with this complaint.

Manufacturer Narrative

Device evaluation: the device has been returned and evaluated by product analysis on 12/08/2016 with the following findings: a review of the pump histories did not find any errors, alarms, or warnings associated with the complaint.The pump successfully completed a rewind, load, and prime sequence.The black box data and histories from the time of the alleged incident were overwritten therefore they were unavailable for review due to continued use of the pump.The available daily insulin delivery totals correctly reflected the user¿s programmed basal rates.The pump passed delivery accuracy testing and was found to be delivering within required specifications.The insulin on board was found to functioning properly but the pump information for the complaint date was overwritten therefore the investigation was unable to duplicate the initial complaint about an ¿inaccurate delivery¿ issue.Animas has conducted a review of the device history record for this pump and confirmed that it was operating within required specifications at the time of release.(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: 5560018
• MDR Text Key: 42503450
• Report Number: 2531779-2016-07374
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 03/25/2016

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: 011084040610005121846060016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 13 MO
• Initial Date Manufacturer Received: 03/25/2016
• Initial Date FDA Received: 04/07/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2015
• 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: 55 YR