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

Device Problem Structural Problem (2506)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device 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) 2017, the reporter contacted animas, alleging a casing/condition (damaged cap and case) issue. It was alleged that the battery cap was unable to be removed. There was no indication that the product caused or contributed to an adverse event. This complaint is being reported because the alleged malfunction 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

Device evaluation: the device has been returned and evaluated by product analysis on 1/28/2017 with the following findings: during visual inspection of the pump, it was observed that the battery compartment was cracked. It was also observed that the threads of the returned battery cap were stripped and were unable to secure to the pump. A test battery cap was used to complete the investigation and it was able to secure to the pump. Animas has conducted a review of the device history record for this pump and confirmed that it was operating within required specifications at the time of release. There was no other physical damage found to the pump.

• 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: 6265605
• MDR Text Key: 65567074
• Report Number: 2531779-2017-01689
• 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: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 01/02/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 01/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: No Information
• Date Manufacturer Received: 01/02/2017
• 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: Unkown