MAUDE Adverse Event Report: INSULET OMNIPOD

Model Number OMNIPOD

Device Problem Insufficient Information (3190)

Patient Problems Hyperglycemia (1905); Pain (1994); Diabetic Ketoacidosis (2364); Sleep Dysfunction (2517)

Event Date 10/22/2015

Event Type  Injury  

Event Description

My (b)(6) daughter, diagnosed at (b)(6) with type 1 diabetes, has been using insulet omnipod for four years.Though some isolated equipment problems sporadically, the recent failures of this omnipod, resulted in high blood sugars and ketoacidosis.Stress beyond belief, trouble in school, missed school, loss of sleep and inflicted illness which further increase blood sugars.Additional pod changes which are extremely painful and many, many tears.Ketoacidosis was treated with additional insulin which were painful boluses as well.Poor kid suffered and was almost hospitalized due to these product failures.Now i am advocating to obtain replacements for these pods in this lot.

• Brand Name: OMNIPOD
• Type of Device: OMNIPOD
• Manufacturer (Section D): INSULET
• MDR Report Key: 5235214
• MDR Text Key: 31580273
• Report Number: MW5057925
• 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: Other
• Type of Report: Initial
• Report Date: 11/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: OMNIPOD
• Device Lot Number: L41904
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: FLOVENT
• Patient Outcome(s): Other
• Patient Age: 9 YR