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

Model Number 19191

Device Problem Material Twisted/Bent (2981)

Patient Problems Hyperglycemia (1905); Nausea (1970); Vomiting (2144); Dizziness (2194); Diabetic Ketoacidosis (2364)

Event Date 12/08/2020

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 the reported hospitalization and diabetic ketoacidosis.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.

Event Description

It was reported by the patient's mother that a patient had been hospitalized with diabetic ketoacidosis (dka).It was reported that the patient's blood glucose levels reached high, over 500 mg/dl while wearing the pod between 4 and 24 hours.Patient also had high ketones, vomiting, nausea, light headed and dizziness.Patient was taken to the emergency room where they were treated with intravenous therapy with insulin drip and fluids.The nurse told the patients mother that the cannula was kinked.

Manufacturer Narrative

No damages were observed with the exposed portion of the soft cannula during investigation.Fluid was observed passing through the fluid path successfully and exiting through the distal tip of the soft cannula.The data downloaded from the device did not show any timeouts or drive stalls during the run.The adhesive pad weld was observed to be misaligned.

• Brand Name: OMNIPOD INSULIN MANAGEMENT SYSTEM
• Type of Device: PUMP, INFUSION, INSULIN
• Manufacturer (Section D): INSULET CORPORATION; 100 nagog park; acton MA 01720
• MDR Report Key: 11100762
• MDR Text Key: 224564074
• Report Number: 3004464228-2020-20358
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 20385081120033
• UDI-Public: (01)20385081120033(11)200803(17)220203(10)L72071
• Combination Product (y/n): N
• PMA/PMN Number: K192659
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/03/2022
• Device Model Number: 19191
• Device Catalogue Number: ZXP425
• Device Lot Number: L72071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2021
• Date Manufacturer Received: 02/23/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 15 YR