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

Device Problems Moisture Damage (1405); Temperature Problem (3022)

Patient Problem Burn(s) (1757)

Event Type  Injury  

Manufacturer Narrative

The device has not been returned to animas.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 and alleged the patient experienced on (b)(6) 2018 a first degree burn with a blister from an alleged temperature issue.Reportedly, the patient resumed pump use after replacement, and was treated with prescription ointment by their healthcare provider via phone advice.During troubleshooting with customer technical support, it was revealed the insulin pump was exposed to a swimming pool/hot tub and had alleged moisture ingress.No damage was alleged to the pump.This complaint is being reported based on the allegation that the patient experienced a first degree burn associated with an alleged temperature issue.

Manufacturer Narrative

Device evaluation: the device has been returned and evaluated by product analysis on 03-aug-2018 with the following findings:.During investigation, the pump is completely unresponsive.There was no audible , vibrate, or screen when battery was inserted.The pump was unresponsive due to moisture corrosion in the battery compartment and on the battery cap ground spring.There was moisture through large battery compartment crack.Power was applied directly to the main pcb in-order to power ee-proms to extract pump d/load history and the black box data.

• Brand Name: ANIMAS VIBE
• Type of Device: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS LLC; 200 lawrence dr; west chester PA 19380 3428
• Manufacturer (Section G): ANIMAS LLC; 200 lawrence dr; west chester PA 19380 3428
• Manufacturer Contact: karin sargrad ; 200 lawrence dr; west chester, PA 19380-3428 ; 4843561808
• MDR Report Key: 7737849
• MDR Text Key: 115646748
• Report Number: 2531779-2018-13810
• Device Sequence Number: 1
• Product Code: OYC
• Combination Product (y/n): Y
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 07/17/2018
• 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 Outcome(s): Life Threatening; Required Intervention
• Patient Age: 61 YR