MAUDE Adverse Event Report: INSULET CORPORATION OMNIPOD 5 CONTROLLER; INTEROPERABLE AUTOMATED GLYCEMIC CONTROLLER

Patient Problem Hypoglycemia (1912)

Event Date 11/24/2023

Event Type  Injury  

Event Description

Pt (patient) uses an omnipod 5 with cgm (continuous glucose monitor).He was at a dinner and went to the car to use his pod controller to bolus.He then walked away from his pod.5 hrs later he was at the hotel and looked at his pod controller which then started initiating the insulin bolus and gave him the (b)(4) units of insulin 5 hrs late.He had no way to stop or cancel the bolus.This resulted in him having a low blood sugar down to 43.The pump should not have bolused insulin 5 hrs late due to the lack of connection.Reference report: mw5148551.

• Brand Name: OMNIPOD 5 CONTROLLER
• Type of Device: INTEROPERABLE AUTOMATED GLYCEMIC CONTROLLER
• Manufacturer (Section D): INSULET CORPORATION
• MDR Report Key: 18237392
• MDR Text Key: 329667915
• Report Number: MW5148552
• Device Sequence Number: 1
• Product Code: QJI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/29/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DEXCOM G6 SENSOR.
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 100 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White