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); Reaction (2414)

Event Date 11/28/2019

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 reported hospitalization and skin reaction to the adhesive pad.No lot release records were reviewed, as the product lot number was not provided.Omnipod insulin management system ¿ user guide, model: ent450, 17845-5c-aw rev a 10/17.Changing your pod 3 / page 23-24: warning: do not use a pod if you are sensitive to or have allergies to acrylic adhesives, or have fragile or easily damaged skin.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 or an alcohol prep swab, and keep sterile materials away from any possible germs.Living with diabetes 11 / page 117: infusion site checks: 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 the patient was hospitalized due to an allergy reaction from the omnipod's adhesive.No other information was provided on this event.

• 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: 9414922
• MDR Text Key: 169205974
• Report Number: 3004464228-2019-12650
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 20385081120033
• UDI-Public: (01)20385081120033
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 11/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 19191
• Device Catalogue Number: ZXP425
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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