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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

This complaint is for the omnipod5 insulin pump system.The first time the problem happened was the friday after thanksgiving.I called the manufacturer.The insulin pod (pump) would not connect to the transmitter that runs it.I was told the problem seemed to be the transmitter had failed.This is not the first time this has happened since i went on this new insulin pump of theirs.So far it has happened 4 additional times.There is no app yet to use instead.Each time they replaced the transmitter and pods.One time they even sent a new one because of a voluntary recall, not counting the four that failed.Without the transmitter the pod will not work or give me basal or bolus insulin.Several times i've had to go back on mdi (multiple dose injection) for this.Three of the transmitters were returned.I have two failed ones in my possession, but have been told to throw them away.Other diabetics i know have complained about the same thing.Reference reports: mw5146310, mw5146311, mw5146313, mw5146314, mw5146315, mw5146316, mw5146317, mw5146318, mw5146319.

• Brand Name: OMNIPOD TRANSMITTER/CONTROLLER
• Type of Device: INTEROPERABLE AUTOMATED GLYCEMIC CONTROLLER
• Manufacturer (Section D): INSULET CORPORATION
• MDR Report Key: 17852819
• MDR Text Key: 324893794
• Report Number: MW5146312
• 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: Patient
• Type of Report: Initial
• Report Date: 09/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2023
• 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
• Patient Sequence Number: 1
• Treatment: HUMALOG INSULIN.; OMNIPOD 5 PUMP.
• Patient Outcome(s): Other
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White