MAUDE Adverse Event Report: INSULET CORP OMNIPOD

Lot Number L40713

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912); Underdose (2542)

Event Type  malfunction  

Event Description

The insulin delivery was noticeably different than another fda approved insulin delivery system.We have seen what we believe are two problems with the omnipod system on a somewhat regular basis.When we first attach and start a new pump, our daughter will go through a period of 4-8 hours where her blood sugar is high.Later, near the end of the 2-3 day life of a pump, we will see the same behavior again.She will have consistently high blood sugar levels that just do not seem to respond to insulin in the same way that they did in the midlife (12-48 hours) of the pump.We have performed an unofficial experiment that backs up our claim with some data.We used our previous insulin delivery system, a novolog insulin pen, to deliver 5 units into a cap that covers the needle that works with that pen.We then took an omnipod pod which we felt was not working near the end of its life (48-72 hours), which we had detached from our daughter without deactivating, and had it deliver 5 units into an identical cap.We put the two caps side by side and compared the levels.We did this test on two different occasions and each time the omnipod system delivered noticeably less insulin.This is consistent with our belief that the omnipod system delivers inconsistent amounts of insulin over its approved 72 hours of use.We have included copies of the pictures we have taken.Frequent high and subsequent low blood sugar levels.

• Brand Name: OMNIPOD
• Type of Device: OMNIPOD
• Manufacturer (Section D): INSULET CORP
• MDR Report Key: 3818024
• MDR Text Key: 4446850
• Report Number: MW5036120
• Device Sequence Number: 2
• Product Code: LZG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 04/28/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Lot Number: L40713
• Patient Sequence Number: 1
• Treatment: INSULIN (NOVOLOG U100); OMNIPOD INSULIN DELIVERY; DEXCOM PLATINUM G4 CONTINUOUS GLUCOSE MONITOR
• Patient Age: 7 YR
• Patient Weight: 25