MAUDE Adverse Event Report: INSULET CORPORATION OMNIPOD 5; ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP

Device Problems Inadequate User Interface (2958); Application Program Problem: Medication Error (3198)

Patient Problem Hypoglycemia (1912)

Event Date 11/12/2022

Event Type  Injury  

Event Description

Insulin dispensed under the automation mode of insulet's omnipod 5 insulin pump is not accounted in the insulin on board tally that is provided by the insulin pump control device (pdm) which is also an insulet manufactured medical device and is a separate device from the omnipod insulin pump pod.The insulin on board tally is relied upon by the insulin pump operator to determine appropriate insulin bolus dosage when a bolus is needed for meals or high glucose level correction.In my episode, the pump had dispensed nearly 3 units of insulin over the course of an hour across 5 minute increments.This was not reflected in the insulin on board tally.So upon being woken by a high glucose alarm, i ordered the pdm to bolus a dosage of insulin relying on the insulin on board tally versus the current glucose status.The bolus plus the existing insulin from the pumps automation in my system was too much and i was awoken later in the evening with a low glucose alarm finding that my glucose was quickly dropping below 47.

• Brand Name: OMNIPOD 5
• Type of Device: ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP
• Manufacturer (Section D): INSULET CORPORATION
• MDR Report Key: 16043560
• MDR Text Key: 306277424
• Report Number: MW5113995
• Device Sequence Number: 2
• Product Code: QRX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Patient Sequence Number: 1
• Treatment: DEXCOM G6 CONSTANT GLUCOSE MONITOR; FIASP U100 ASPART INSULIN
• Patient Outcome(s): Life Threatening
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian, White