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

Device Problems Electrical /Electronic Property Problem (1198); Moisture Damage (1405)

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) 2016, the reporter contacted animas, alleging a power (moisture ingress) issue.It was alleged that there was moisture in the battery compartment and there was no power.There was no indication that the product caused or contributed to an adverse event.This issue is being reported because the user may be unaware that the pump has lost power, leading to under delivery.

Manufacturer Narrative

The device has been returned and evaluated by product analysis on 02/13/2017 with the following findings: during investigation, there were pump reboots observed in the black box.The pump was returned with no evidence of moisture in the battery compartment.The contract button was the only operable button on the keypad.A leak test failed due to a bolus button leak.There was no physical damage on the keypad.The keypad was removed and there was no defect found.The bolus button cover was removed and there was moisture observed on the button contact.The pump was opened and there was moisture observed throughout the pump casing.It was concluded that the keypad buttons were inoperable due to a bolus button short.Unrelated to the original complaint, the battery compartment was observed to be cracked.A leak test did not show any evidence of a leak at the battery compartment crack.

• 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: 6216702
• MDR Text Key: 63820454
• Report Number: 2531779-2016-35143
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 10840406100013
• UDI-Public: 0110840406100013
• 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: 12/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2016
• 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: 12/21/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 12/08/2016
• 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: 55 YR