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

Device Problems Moisture Damage (1405); Failure to Read Input Signal (1581)

Patient Problem No Consequences Or Impact To Patient (2199)

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) 2018, the reporter contacted animas alleging a button/keypad (abb tactile changes w/moisture) issue.It was reported that the audio bolus button was damaged and was under responsive to user presses and there was moisture present in the cartridge compartment.There is no indication that the product issue caused or contributed to an adverse event.This complaint is being reported because the issue has the ability to result in inadvertent or incorrect boluses which may result in over or under delivery.

Manufacturer Narrative

Device evaluation: the device has been returned and evaluated by product analysis on 16-feb-2018 with the following findings: during investigation, a visual inspection of the pump revealed no evidence of moisture in the cartridge compartment.No physical damage was observed on the audio bolus button cover.The audio bolus button was unresponsive during testing.The audio bolus button cover was removed and no defect was found.A leak test failed due to a case seal leak.The pump was opened and moisture was found on keypad flex connector.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: 7246725
• MDR Text Key: 99308061
• Report Number: 2531779-2018-02877
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P130007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other Caregivers
• Type of Report: Initial,Followup
• Report Date: 01/28/2018

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 01/28/2018
• Initial Date FDA Received: 02/06/2018
• Supplement Dates Manufacturer Received: 01/28/2018
• Supplement Dates FDA Received: 02/27/2018
• 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: 39 YR