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

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device has been returned to animas.Evaluation has not yet been completed.When evaluation is complete a supplemental report will be filed.No conclusion can be made at this time.

Event Description

On (b)(6) 2017, the reporter contacted animas, alleging a power (no power) issue.There was no indication that the product caused or contributed to an adverse event.This issue is being reported because the user may be unaware that the pump has lost power, leading to under delivery.

Manufacturer Narrative

Follow-up #1: date of submission 03/24/2017 device evaluation: the device has been returned and evaluated by product analysis on 03/03/2017 with the following findings: a review of the black box showed power on reset events.The pump was powered on properly.The rewind, load, and prime steps were performed successfully.The pump was run for 24 hours and no power issues occurred.The power complaint could not be duplicated.Unrelated to the original complaint, the battery compartment was cracked at the threads to the left side of the grip pad down to the seal.The battery cap was able to fit for testing.Moisture was found in the battery compartment.A leak test was performed and failed due to a leak in the battery compartment.The pump was opened to find moisture on the continuous glucose monitoring module.(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: 6278257
• MDR Text Key: 65941720
• Report Number: 2531779-2017-02116
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 10840406100051
• UDI-Public: 0110840406100051
• 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: 01/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2017
• 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: 01/24/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 01/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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: 20 YR