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

Model Number 18320

Device Problem Insufficient Information (3190)

Patient Problems Inflammation (1932); Pain (1994); Skin Infection (4544); Skin Inflammation/ Irritation (4545)

Event Date 03/05/2022

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 the patient developed an infection at the pod¿s insertion site while wearing the device for longer than 48 hours.Upon removal of the pod from the infusion site the patient reports inflammation, irritation, pain and redness at the pod infusion site.The patients reported blood glucose level was 200 mg/dl.The patient is a wound care doctor and was able to diagnose the pod site with an infection.As treatment, the patient had prescribed themselves a topical antibiotic of silvadene (1 %) to be applied 3 times daily.In addition the patient administered manual insulin.

Manufacturer Narrative

The returned device was evaluated and inspection of the device found no issues capable of causing the reported infection nor pain.The causes of these events could not be determined.

• 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: michael spears ; 100 nagog park; acton, MA 01720 ; 9786007000
• MDR Report Key: 13788606
• MDR Text Key: 287351570
• Report Number: 3004464228-2022-04374
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 20385082000020
• UDI-Public: (01)20385082000020(11)210813(17)230213(10)PD1C08132141
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/13/2023
• Device Model Number: 18320
• Device Catalogue Number: BLE-I1-529
• Device Lot Number: PD1C08132141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/13/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female