MAUDE Adverse Event Report: INSULET OMNIPOD

Model Number UST400-FAOB

Device Problem Failure to Deliver (2338)

Patient Problems Hyperglycemia (1905); Complaint, Ill-Defined (2331)

Event Date 01/01/2016

Event Type  Injury  

Event Description

The freestyle omnipod's failed to deliver insulin.They report that it is from pod failure, but i believe it is much more than that.I have tried contacting the manufacturer for a refund, and additional people who are supposed to call me back have failed to do so.My alc has increased, and my kidneys are showing damage from inefficient delivery of insulin.This began to happen at the end of last year, but i was guaranteed that other pods delivered insulin fine.I am proof that they don't.I have spent many precious hours trying to get the company to resolve this and my problem, but they refuse to move forward and do the right thing.I cannot afford to purchase another device until i receive a refund.I have had blood sugars 400 and even above, this is affecting my life in a very negative manner, and the device needs to be taken off the market until a solution is figured out.People like me have suffered from high blood sugars which come with terrible side effects.The device and the company need to be investigated and closed until the units no longer damage individuals health.

• Brand Name: OMNIPOD
• Type of Device: OMNIPOD
• Manufacturer (Section D): INSULET
• MDR Report Key: 5587804
• MDR Text Key: 43197479
• Report Number: MW5061794
• Device Sequence Number: 1
• 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: 04/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: UST400-FAOB
• Device Lot Number: 130129583
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Disability
• Patient Age: 53 YR
• Patient Weight: 63