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

Model Number 19191

Device Problem Insufficient Information (3190)

Patient Problems Irritation (1941); Pain (1994); Ambulation Difficulties (2544)

Event Date 11/15/2018

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 customer's infusion site infection and er visit.Lot release and sterilization records were reviewed and the product lot met all acceptance criteria.Omnipod insulin management system ¿ user guide.Model: ent450.17845-5c-aw rev a 10/17.Changing your pod 3 / page 24.Warning: to minimize the possibility of site infection, do not apply a pod without first using aseptic technique.This means to wash your hands, clean the insulin vial with an alcohol prep swab, clean the infusion site with soap and water and keep sterile materials away from any possible germs.Changing your pod 3 / page 34.Warning: if an infusion site shows signs of infection; immediately remove the pod and apply a new one at a different site.Contact your healthcare provider.Treat the infection according to instructions from your healthcare provider.Living with diabetes 11 / page 117.At least once a day, use the pod¿s viewing window to inspect the infusion site.Check the site for signs of infection, such as pain, swelling, redness, discharge or heat.

Event Description

It was reported that after wearing the pod on the leg between 24 and 36 hours, the site was painful, red and hot to the touch with difficulty to walk.The patient visited the emergency room (er) where he was treated with intravenous (iv) antibiotics for 4 days (name not specified) and given additional 10 days to be taken upon discharge.

Manufacturer Narrative

The returned device was evaluated and no damages or defects were found during investigation that would contribute to an infection.The cause of the reported event could not be determined.

• Brand Name: OMNIPOD INSULIN MANAGEMENT SYSTEM
• Type of Device: PUMP, INFUSION, INSULIN
• Manufacturer (Section D): INSULET CORPORATION; 100 nagog park; acton MA 01720
• Manufacturer (Section G): INSULET CORPORATION; 100 nagog park; acton MA 01720
• Manufacturer Contact: jordan biswurm ; 100 nagog park; acton, MA 01720 ; 9786007000
• MDR Report Key: 9852859
• MDR Text Key: 184074880
• Report Number: 3004464228-2020-03893
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 20385081120033
• UDI-Public: (01)20385081120033(11)180615(17)191215(10)L43966
• 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,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/15/2019
• Device Model Number: 19191
• Device Catalogue Number: ZXP425
• Device Lot Number: L43966
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2020
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/12/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2018
• 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 Outcome(s): Hospitalization; Required Intervention