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

Device Problem Premature Discharge of Battery (1057)

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) 2017, the reporter contacted animas, alleging a power (battery life) issue.There was no indication that the product caused or contributed to an adverse event.The issue is being reported because it may result in a long term cessation of insulin delivery if the user is unable to resolve the alarm.

Manufacturer Narrative

Follow-up #1: date of submission 03/30/2017 device evaluation: the device has been returned and evaluated by product analysis on 03/08/2017 with the following findings: a review of the black box showed frequent low battery warnings in the alarm history.The rewind, load, and prime steps were performed successfully.The pump electrical current draws were tested and were within specifications.(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: 6268795
• MDR Text Key: 65672570
• Report Number: 2531779-2017-01813
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 10840406100068
• UDI-Public: 0110840406100068
• 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: 01/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2017
• 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: 01/25/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 01/03/2017
• 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: 56 YR
• Patient Weight: 125