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

Device Problems Moisture Damage (1405); Structural Problem (2506)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The pump 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) 2016, the reporter contacted animas, alleging a casing/condition (case damage w/moisture) issue.It was reported that the battery compartment was damaged and there was moisture in the pump.There was no indication that the product caused or contributed to an adverse event.This complaint is being reported because the reported issue has the ability to result in a delay in treatment or long term cessation in delivery if the damage impacts the power circuit or cartridge compartment.

Manufacturer Narrative

Follow-up #1: date of submission 09/29/2016 device evaluation: the device has been returned and evaluated by product analysis on 09/06/2016 with the following findings: during investigation, moisture damage was observed in the battery compartment.A crack in the battery compartment was found from the threads to the case seal left of the grip pad.A leak test was performed and failed due to a leak in the battery compartment.The pump was opened to find no further moisture.

Manufacturer Narrative

Follow-up #2 date of submission 10/07/2016 - correction to serial #.

• 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: 5870783
• MDR Text Key: 52907875
• Report Number: 2531779-2016-20378
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 10840406100099
• UDI-Public: 0110840406100099
• 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: 07/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2016
• 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: 08/03/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 9 MO
• Date Manufacturer Received: 07/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 162