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

Device Problem Moisture Damage (1405)

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

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 casing/condition (moisture ingress) issue.It was reported that there was moisture behind the display.There is no indication that the product issue 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

Follow-up # 1 date of submission 9/20/2016.Device evaluation: the device has been returned and evaluated by product analysis on 8/27/2016 with the following findings: during visual inspection of the pump, it was observed that there was moisture observed behind the display lens.A leak test was performed and failed due to the display lens leak.The pump was opened and there was evidence of moisture throughout the internal areas of the pump.Unrelated to the initial complaint, it was observed that the audio bolus button cover was damaged but the bolus button was responsive during the investigation.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.

• 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: 5820136
• MDR Text Key: 51007482
• Report Number: 2531779-2016-17321
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• PMA/PMN Number: P130007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 07/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2016
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 07/06/2016
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 62 YR