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

Model Number 19191

Device Problem Insufficient Information (3190)

Patient Problems Skin Discoloration (2074); Skin Infection (4544); Skin Inflammation/ Irritation (4545)

Event Date 12/26/2020

Event Type  Injury  

Manufacturer Narrative

The device has not been returned/received to date.If the device is received, a supplemental report will be submitted with the investigation results.We are unable to determine if any product condition could have contributed to customer's infusion site infection.Lot release records were reviewed and the product lot met all acceptance criteria.The omnipod is iso10993 compliant, undergoing cytotoxicity, sensitization, genotoxicity, hemolysis, irritation or intracutaneous reactivity, systemic toxicity, and implantation effects testing.The omnipod is sterilized with 100% ethylene oxide gas with a sterility assurance level of 10-6 ¿per iso11135¿ and eo residual levels in compliance with iso10993.Each lot ¿is confirmed to meet requirements for non-pyrogenicity per iso10993 and sterility per iso11135 prior to release.

Event Description

It was reported that a skin irritation causing a green spot, irritation and drainage had occurred while wearing the pod for longer than 48 hours.Patient visited physician and was prescribed fucidin cream to treat the irritation on the leg.

• 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: 11278056
• MDR Text Key: 230221615
• Report Number: 3004464228-2021-01599
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 20385081120033
• UDI-Public: (01)20385081120033(11)200827(17)220227(10)L45973
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192659
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/27/2022
• Device Model Number: 19191
• Device Catalogue Number: ZXP425
• Device Lot Number: L45973
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 9 YR