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

Device Problem Device Issue (2379)

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 10/05/2016, the reporter contacted animas alleging that the battery compartment ¿smelled smokey¿ and there was something in the compartment.There was no allegation of an adverse event with this complaint.This complaint is being reported based on the allegation of a non-specific pump malfunction.

Manufacturer Narrative

The device has been returned and evaluated by product analysis on 12/12/2016 with the following findings: during investigation, there was corrosion observed in the battery compartment.A leak test was performed and failed at the battery compartment leak due to a crack above the bumper 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: 6069272
• MDR Text Key: 59125313
• Report Number: 2531779-2016-30210
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 10840406100037
• UDI-Public: 0110840406100037
• 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: 10/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 10/31/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 13 MO
• Initial Date Manufacturer Received: 10/05/2016
• Initial Date FDA Received: 11/01/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/2015
• 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: 39 YR