MAUDE Adverse Event Report: INSULET CORPORATION OMNIPOD

Lot Number L41897, L41898

Device Problem Insufficient Information (3190)

Patient Problem Hyperglycemia (1905)

Event Date 11/04/2015

Event Type  Injury  

Event Description

My son has been using the omniopod system for about four weeks.During those four weeks he has experienced numerous episodes of hyperglycemia after insertion of new pods.He had to go to the emergency room and to his doctor using this period due to hyperglycemia and medical illnesses caused by his hyperglycemia.

• Brand Name: OMNIPOD
• Type of Device: OMNIPOD
• Manufacturer (Section D): INSULET CORPORATION
• MDR Report Key: 5210435
• MDR Text Key: 30839709
• Report Number: MW5057739
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 11/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Lot Number: L41897, L41898
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 6 YR
• Patient Weight: 25