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); Itching Sensation (1943); Reaction (2414)

Event Date 12/01/2019

Event Type  Injury  

Manufacturer Narrative

The product was not returned for evaluation.We are unable to assess if any product condition could have contributed to the patient's skin irritation.No lot release and sterilization records were reviewed because no product lot number was reported.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 23.Warning: do not use a pod if you are sensitive to or have allergies to acrylic adhesives, or have fragile or easily damaged skin.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 between 24 and 36 hours on the abdomen the patient's site was itchy, painful and that she had an allergic reaction.She went to see her general practitioner who prescribed her a cream (exact name of the cream was not provided) for her site irritation.

• 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: 9569949
• MDR Text Key: 174518085
• Report Number: 3004464228-2020-00191
• 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
• Type of Report: Initial
• Report Date: 01/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2020
• 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
• Date Manufacturer Received: 01/01/2020
• 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 Age: 53 YR