MAUDE Adverse Event Report: INSULET CORPORATION OMNIPOD INSULIN POD

Lot Number L41897

Device Problem Positioning Failure (1158)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/10/2015

Event Type  malfunction  

Event Description

Our son has an omnipod insulin pump.He has had 3 pods that failed to deploy the needle and insert, but when deactivated and taken off and set down with a little jolt all three deployed after removal.First 2 pods were on (b)(6) 2015, the 3rd was (b)(6) 2015.

• Brand Name: OMNIPOD INSULIN POD
• Type of Device: OMNIPOD INSULIN POD
• Manufacturer (Section D): INSULET CORPORATION
• MDR Report Key: 5207721
• MDR Text Key: 30709701
• Report Number: MW5057709
• 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: 11/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 01/01/2017
• Device Lot Number: L41897
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/03/2015
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 5 YR
• Patient Weight: 18