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

Device Problem Temperature Problem (3022)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The device has been returned and evaluated by product analysis on 09/29/2017 with the following findings: the black box was reviewed and confirmed that the voltage was steady with no sudden drop prior to the reported temperature event.

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 that there was a temperature issue with the pump. This complaint is being reported because the reported issue was not resolved with troubleshooting. There was no indication that the product caused or contributed to an adverse event.

Manufacturer Narrative

Follow-up #1: date of submission (b)(6) 2016 device evaluation: the device has been returned and evaluated by product analysis on (b)(6) 2016 with the following findings: no unusual voltage fluctuation that could cause the pump to get hot was observed in the black box. A replace battery alarm was observed on (b)(6) 2016 due a discharged battery being used. The prime steps were performed correctly and all currents draws were within specifications. There was no overheating or any temperature issues observed.

• 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: 5478502
• MDR Text Key: 104583601
• Report Number: 2531779-2016-05200
• 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,Followup
• Report Date: 02/28/2016

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Other Device ID Number: 011084040610009921258327116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 2 MO
• Event Location: No Information
• Date Manufacturer Received: 02/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown