MAUDE Adverse Event Report: INSULET CORPORATION OMNIPOD INSULIN MANAGEMENT SYSTEM; PUMP, INFUSION, INSULIN

Model Number 19191

Device Problem Unintended Movement (3026)

Patient Problems Skin Irritation (2076); Caustic/Chemical Burns (2549)

Event Date 07/21/2019

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation.We are unable to determine if any product condition could have contributed to the skin irritation/chemical burn.Lot release and sterilization records were reviewed and the product lot met all acceptance criteria.Omnipod insulin management system ¿ user guide.Model: ust400.17845-5a-aw rev b 09/17.Changing your pod.Chapter 3 / page 23.Warnings: do not use a pod if you are sensitive to or have allergies to acrylic adhesives, or have fragile or easily damaged skin.If you are a first-time omnipod system user, your omnipod system trainer will guide you through the steps for initializing and applying your first pod.Do not attempt to apply or use a pod until you have been trained by your omnipod system trainer.Use of the system with inadequate training or improper setup could put your health and safety at risk.Living with diabetes.Chapter 11 / page 115.Infusion site checks.At least once a day, use the pod's viewing window to inspect the infusion site.Check the site for: leakage or scent of insulin, which may indicate the cannula has dislodged.Signs of infection, such as pain, swelling, redness, discharge or heat.

Event Description

The patient report that at around 4 am, she woke up to feeling a wetness on her skin where the pod was on her abdomen.She believes that the cannula dislodged from her skin when she was sleeping.Her blood glucose reached 245mg/dl.She went to the urgent care later in the morning.Once there, the patient was diagnosed with a chemical burn that went through the dermis layer of her skin and into the epidermis.The pa (physician assistant) prescribed silvadene usp 1% cream to apply twice daily.Other instructions for care were to keep the area clean, dry, and covered by a (b)(6); as well as to watch for signs of infection.If the customer were to see increased redness, streaks, or discharge indicating a potential infection, she is to see her primary care doctor or return to the clinic immediately.The pod was worn longer than 48 hours.

Manufacturer Narrative

The received device had the cannula assembly deployed.The downloaded data returned an alarm, indicating that a communication error occurred while the device was waiting for input from the pdm.Inspection of the device found no evidence that would result in skin irritation occurring at the infusion site; a root cause could not be determined.No evidence was found that would result in the cannula dislodging; a root cause could not be determined.No leaks in the fluid path were found.No evidence was found that would result in a communication error occurring; a root cause could not be determined.No other defects or deficiencies were found that would result in a failure of the device to deliver insulin.(device available for eval: yes, date returned to mfg: 8/5/2019) the device had been received at the time of initial report.(device returned to manufacturer? yes) the device had been returned to the manufacturer at the time of initial report.

• Brand Name: OMNIPOD INSULIN MANAGEMENT SYSTEM
• Type of Device: PUMP, INFUSION, INSULIN
• Manufacturer (Section D): INSULET CORPORATION; 600 technology park drive; suite 200; billerica MA 01821
• Manufacturer (Section G): INSULET CORPORATION; 600 technology park drive; suite 200; billerica MA 01821
• Manufacturer Contact: derek sammarco ; 600 technology park drive; suite 200; billerica, MA 01821 ; 9786007000
• MDR Report Key: 8873487
• MDR Text Key: 153658896
• Report Number: 3004464228-2019-07354
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 20385081120033
• UDI-Public: (01)20385081120033(11)190316(17)200916(10)L44676
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162296
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/16/2020
• Device Model Number: 19191
• Device Catalogue Number: ZXP425
• Device Lot Number: L44676
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2019
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 51 YR