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

Device Problem Temperature Problem (3022)

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 temperature (temp - no physical damage) issue.There was no reported bodily injury due to the temperature issue.This complaint is being reported because there is the potential for the user to experience an injury to the skin due to increased pump temperature.

Manufacturer Narrative

Follow-up #1: date of submission 02/01/2017 device evaluation: the device has been returned and evaluated by product analysis on 01/24/2017 with the following findings: a review of the black box showed no evidence of unusual voltage fluctuations.The rewind, load, and prime steps were performed successfully.The battery cap was undamaged and was able to fit securely.All currents read within specification.No overheating occurred during the investigation.The pump cover was removed to find no intermittent conditions to the printed circuit board or the continuous glucose monitoring module.The complaint of a temperature issue was unable to be duplicated.Unrelated to the original complaint the battery compartment was cracked below the grip pad.

• 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: 6131924
• MDR Text Key: 61242342
• Report Number: 2531779-2016-32385
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 10840406100280
• UDI-Public: 0110840406100280
• 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: 11/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2016
• 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: 11/30/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 6 MO
• Date Manufacturer Received: 11/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2016
• 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: 12 YR
• Patient Weight: 62