MAUDE Adverse Event Report: INSULET CORP OMNIPOD INSULIN PUMP; PUMP, INFUSION, INSULIN

Model Number 14000

Device Problem Failure To Adhere Or Bond (1031)

Patient Problems Chest Pain (1776); Hyperglycemia (1905)

Event Date 09/09/2014

Event Type  Injury  

Event Description

The customer's mother reported on (b)(6) 2014 her daughter's blood glucose history is as follows: time: 2:18pm, bg(mg/dl): 300, time: 11:43pm, bg(mg/dl): 383.She stated that the pod was not sticking to her skin while she was at school.She was having chest pains and trouble breathing so she took her to the emergency room.She also mention that the pod was not sticking to her skin.She stayed at the emergency room for about 12 to 13 hours before they finally got her ketone levels down and she was feeling better.

Manufacturer Narrative

The product was not returned for evaluation.We are unable to determine if any defect could have contributed to the reported adhesion issue, hyperglycemia and hospitalization.Qualification records were reviewed and the product lot met all acceptance criteria.

• Brand Name: OMNIPOD INSULIN PUMP
• Type of Device: PUMP, INFUSION, INSULIN
• Manufacturer (Section D): INSULET CORP; bedford MA
• Manufacturer Contact: michael doyle ; 600 technology park drive; ste 200; billerica, MA 01821 ; 9786007000
• MDR Report Key: 4196364
• MDR Text Key: 4962499
• Report Number: 3004464228-2014-01510
• Device Sequence Number: 1
• Product Code: LZG
• Combination Product (y/n): N
• PMA/PMN Number: K122953
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/01/2016
• Device Model Number: 14000
• Device Catalogue Number: ZXP425
• Device Lot Number: L41234
• Other Device ID Number: 0501108
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 17 YR