MAUDE Adverse Event Report: INSULET OMNIPOD

Model Number OMNIPOD

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 07/11/2013

Event Type  malfunction  

Event Description

My (b)(6) year old son has type 1 diabetes, and has used the insulet omnipod insulin pump to manage his diabetes since (b)(6) 2009.In early 2013, insulet announced approval of new, smaller omnipod system.In early july 2013, we transitioned my son to the new system.Since that time, we have experienced a very high rate of pump failures compared to the previous omnipod.Specifically, the omnipod has alarmed and deactivated on 29 separate occasions between (b)(6) 2013, and (b)(6) 2014.Many of the failures occurred in less than 48 hours of use, with some occurring after as little as three hours of use.Approx.76 of the pods have worked normally, resulting in a 28% failure rate (29/105 total pods to date).Eighteen (18) of the 29 failures have occurred in (b)(6) 2013 and (b)(6) 2014 alone.We have not been able to determine a consistent pattern for when the pods fail.The failures have been during delivery of bolus insulin, near the end of an extended insulin bolus, and during times of regular basal insulin delivery.The failed pods have also been on various locations of my son's body (arms, legs, abdomen), and don't seem to exhibit a consistent pattern with that either.My son is rather lean, but has had generally the same build over the last five years of using the omnipod.Insulet has been very accommodating in replacing the failed pods and having us send the malfunctioning pods back to them for analysis, but the problem seems to be getting worse.My son has not had any adverse health effects from these failed omnipods.However, the failures are adding unwelcome disruption to his school and home life.In addition, the failed pods are resulting in the disposal of the insulin used to fill the pods.I estimate that we have disposed of approximately 50 units of insulin per pod, or 1450 units total.This waste is costing my insurance company thousands of dollars.If other omnipod users are having similar problems, the resulting financial loss is troubling.The (b)(4) failed pods have come from lot numbers 40418 (10), 40563 (7), 40709 (1), 40718 (5), 40719 (2), 40737 (2), 40785 (1), and 40805 (1).I do not have the "sequence numbers" from each failed omnipod, but all failures have been reported to the company and contain that info.

• Brand Name: OMNIPOD
• Type of Device: OMNIPOD
• Manufacturer (Section D): INSULET
• MDR Report Key: 3603244
• MDR Text Key: 4094271
• Report Number: MW5034120
• Device Sequence Number: 29
• Product Code: LZG
• 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: 01/28/2014
• 29 Devices were Involved in the Event: 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: OMNIPOD
• Device Lot Number: 40805
• Patient Sequence Number: 1
• Patient Age: 7 YR
• Patient Weight: 29