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

Model Number 18320

Device Problem Insufficient Information (3190)

Patient Problems Abscess (1690); Fever (1858); Hyperglycemia (1905); Inflammation (1932); Pain (1994); Diabetic Ketoacidosis (2364)

Event Date 04/26/2023

Event Type  Injury  

Event Description

It was reported that the patient developed pain, infection with an inflamed abscess at the pod¿s insertion site (hip/buttocks) area and was hospitalized with diabetic ketoacidosis (dka) blood glucose levels exceeding 400 mg/dl and a fever.At the hospital the abscess was surgically removed.The patient was prescribed antibiotics (name unspecified), cutimed sorbact absorbent pads, foam bandage, cutimed hydrogel, fixomulll stretch, humalog for quickpen injection, dd microfine pen needles and basaglar injection fluid.The patient was discharged from the hospital after 7 days.Ambulant medical services visits the patient at home to clean the abscess wound once a day until the wound has fully healed.

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 the reported hospitalization and diabetic ketoacidosis.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.Specifically, a pod is paired to a pdm and put through simulated use testing including communicating with the pdm, deployment, delivering fluid, occlusion detection, and freedom from hazard alarms.The omnipod is iso10993 compliant, undergoing cytotoxicity, sensitization, genotoxicity, hemolysis, irritation or intracutaneously 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.

• Brand Name: OMNIPOD DASH 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: thom mcnamara ; 100 nagog park; acton, MA 01720 ; 9786007000
• MDR Report Key: 16918045
• MDR Text Key: 315067483
• Report Number: 3004464228-2023-12273
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 20385082000020
• UDI-Public: (01)20385082000020(11)220527(17)231127(10)PD1K05272221
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K211575
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/27/2023
• Device Model Number: 18320
• Device Catalogue Number: BLE-I1-529
• Device Lot Number: PD1K05272221
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 24 YR
• Patient Sex: Female