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

Model Number 14000

Device Problem Insufficient Information (3190)

Patient Problems Skin Irritation (2076); Reaction (2414)

Event Date 11/26/2019

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 and allergic reaction.No lot release records were reviewed, as the product lot number was not provided.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 patients mother stated that the patient had to go to the emergency room due to an allergy to the pods adhesive.The patient was diagnosed with anaphylactic shock because they administered an epipen into the patient because of the allergic reaction.Patient was monitored and referred to a dermatologist.

• Brand Name: OMNIPOD INSULIN PUMP
• 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: 9494887
• MDR Text Key: 173452419
• Report Number: 3004464228-2019-13340
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 20385081120002
• UDI-Public: (01)20385081120002
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122953
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 14000
• Device Catalogue Number: ZXP425
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/26/2019
• 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
• Patient Age: 8 YR