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

Device Problem Crack (1135)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  No Answer Provided  

Manufacturer Narrative

Device evaluation: the pump has been returned and evaluated by product analysis on 06/30/2016 with the following findings: investigation revealed a crack in the battery compartment.(b)(6).

Event Description

The pump was returned for investigation.Investigation revealed a crack in the battery compartment.There was no adverse event associated with this complaint.This report is made based on results of investigation completed on 07/01/2016.

• 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: 5813437
• MDR Text Key: 50860950
• Report Number: 2531779-2016-17072
• Device Sequence Number: 1
• Product Code: MDS
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/01/2016

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: 011084040610008221595883916
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 16 MO
• Initial Date Manufacturer Received: 07/01/2016
• Initial Date FDA Received: 07/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2015
• 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: 62 YR
• Patient Weight: 156