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

Model Number	14500-5A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Dehydration (1807); Hyperglycemia (1905); Nausea (1970); Vomiting (2144); Elevated ketones/Diabetic Ketoacidosis (2364)
Date of Event	11/25/2023
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported that the patient went to the hospital and was diagnosed with diabetic ketoacidosis (dka) and blood glucose (bg) values that reached 405 mg/dl.The patient was nauseous and vomiting.For treatment, the patient was given fluids, anti-nausea medication, and insulin.The patient was discharged after 1 day.The pod was worn between 4 and 24 hours on the arm.
Additional Manufacturer Narrative
In the case description, the user mentioned having high bgs while using the system.Inspection of the ibf data from the returned device showed no evidence of issues with insulin delivery.The data showed that the user's basal program was running consistently with no indications of stoppage and all boluses programmed by the user were successfully delivered.During the investigation, no issues were observed with the functionality of the pdm and inspection of the internal components found no damages or manufacturing deficiencies that would result in a failure to deliver insulin.The system was found to function as intended.
Additional Manufacturer Narrative
Correction to d(1): from "omnipod insulin management system" to "omnipod insulin pump" correction to d(4)model: from "19191" to "14500-5a".Correction to d(4)lot : from "l72459" to "l60658".Correction to d(4)catalog: from "zxp425" to "ust400".Correction to d(4)serial: added "(b)(6)".Correction to d(4)udi: from "(b)(4)" to "(b)(4)".Correction to h(4): from "12/01/2022" to "5/9/2017".

• Brand Name: OMNIPOD INSULIN PUMP
• Common Device Name: 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: 18364511
• Report Number: 3004464228-2023-36087
• Device Sequence Number: 7697543
• Product Code: LZG
• UDI-Device Identifier: 10385081140003
• UDI-Public: (01)10385081140003(11)170509(10)L60658
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K211575
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/01/2024
• Device Model Number: 14500-5A
• Device Catalogue Number: UST400
• Device Lot Number: L60658
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/27/2023
• Supplement Date Received by Manufacturer: 11/27/2023; 01/12/2024
• Initial Report FDA Received Date: 12/20/2023
• Supplement Report FDA Received Date: 01/11/2024; 01/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 50 YR
• Patient Sex: Female