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

Model Number 19191

Device Problem Insufficient Information (3190)

Patient Problems Hypoglycemia (1912); Loss of consciousness (2418)

Event Date 04/19/2023

Event Type  Injury  

Manufacturer Narrative

We are unable to determine if any product condition could have contributed to the reported hospitalization and hypoglycemia.No lot release records were reviewed, as the product lot number was not provided.

Event Description

It was reported that the patient had been hospitalized with hypoglycemia.The patient's blood glucose levels decreased to 40 mg/dl while wearing the pod between 36 and 48 hours on the arm.The patient loss consciousness and the patient's mother injected her with a shot of glucagon.Emergency services were called and the patient was transported to the hospital where the patient was treated with fluids and glucose.The patient was discharged the following day.

• Brand Name: OMNIPOD 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: 16794085
• MDR Text Key: 313802049
• Report Number: 3004464228-2023-10347
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 20385081120033
• UDI-Public: (01)20385081120033
• 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: 04/19/2023

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
• Device Operator: Lay User/Patient
• Device Model Number: 19191
• Device Catalogue Number: ZXP425
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/19/2023
• Initial Date FDA Received: 04/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization