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	Hyperglycemia (1905); Vomiting (2144)
Date of Event	03/04/2024
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 hyperglycemia.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 had been hospitalized with hyperglycemia.The patient's blood glucose levels reached 400 mg/dl.The patient reported that the controller stopped working for three days.Symptoms reported include vomiting and severe tooth pain.The patient was taken by ambulance to the hospital.Once at the hospital the patient was treated with intravenous fluids as well as insulin.The patient was prescribed clindamycin (150 mg) to be taken 3 times a day.The patient was discharged from the hospital after 7 hours.

• 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: 18865334
• Report Number: 3004464228-2024-08593
• Device Sequence Number: 3314287
• Product Code: LZG
• UDI-Device Identifier: 10385081140003
• UDI-Public: (01)10385081140003
• 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
• Report Date (Section B): 03/08/2024

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 Model Number: 14500-5A
• Device Catalogue Number: UST400
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/04/2024
• Initial Report FDA Received Date: 03/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 25 YR
• Patient Sex: Male