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

Model Number 18900-5C

Device Problem Failure to Read Input Signal (1581)

Patient Problem Hyperglycemia (1905)

Event Date 05/26/2021

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 er visit 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 Description

It was reported that the patient visited the emergency room (er) due to high blood glucose (bg) levels of 18.3 mmol/l (329.4 mg/dl) with ketones present.The patient stated that the omnipod personal diabetes manager (pdm) is not working properly when inputting the blood readings to correct and deliver bolus.At the hospital, the patient was given insulin through a manual injection.

• 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: jordan biswurm ; 100 nagog park; acton, MA 01720 ; 9786007000
• MDR Report Key: 11917888
• MDR Text Key: 253802969
• Report Number: 3004464228-2021-08554
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 10385081120067
• UDI-Public: (01)10385081120067(11)180717(10)L60489
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192659
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/26/2021

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 18900-5C
• Device Catalogue Number: ENT450
• Device Lot Number: L60489
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/26/2021
• Initial Date FDA Received: 06/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2018
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 35 YR