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

Model Number 18900-5T

Device Problem Application Program Problem: Parameter Calculation Error (1449)

Patient Problems Loss of consciousness (2418); Hypoglycemic Shock (4575)

Event Date 05/02/2021

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 hypoglycemia.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 that the patient was taken to the hospital via ambulance due to low blood glucose (bg) levels of 3.6 mmol/l (64.8 mg/dl) and fainting, while using the omnipod device.The patient's personal diabetes manager (pdm) meter was reading incorrectly, which drove the patient to deliver more insulin than needed resulting in an insulin shock through overdose.The patient was administered glucose orally in form of gel.

Manufacturer Narrative

Customer reports inaccurate bg readings.During the bg meter test, it was noted that the device was set to calibration code 8.Customer reports specifically that they are using freestyle lite strips that require code 16.Based on the strip simulation tester, blood glucose readings were found to be within specification and record successfully into the device memory.During the bg meter strip insertion verification test, the pdm recognized the activities and registered readings immediately.Data downloaded from the device indicate all but two measurements on the date of occurrence for the medical event were performed by the bg meter, the remainder were manual entries.

• 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: 11767393
• MDR Text Key: 248787891
• Report Number: 3004464228-2021-06537
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 10385081120166
• UDI-Public: (01)10385081120166(11)180904(10)L60981
• 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,foreign
• Type of Report: Initial,Followup
• Report Date: 05/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 18900-5T
• Device Catalogue Number: DAT450
• Device Lot Number: L50058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2021
• Date Manufacturer Received: 06/30/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 14 YR