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

Model Number 14000

Device Problem Unintended Movement (3026)

Patient Problems Hyperglycemia (1905); Vomiting (2144)

Event Date 03/07/2014

Event Type  Injury  

Event Description

The customer's parent reported on (b)(6) their (b)(6) autistic son was hospitalized and his blood glucose, carbohydrate intake and insulin history is as follows.At 11:00 he was vomiting so they called his doctor who advised them to take him to the emergency room.At 13:00 he was hospitalized in the intensive care unit and was placed on an intravenous therapy of insulin.The pod was removed, they then noticed the cannula was folded over and it was totally dried.The next morning (b)(6) his bg was reading 119 mg/dl and the hospital staff accidently disconnected the iv of insulin and the left the iv of glucose on instead.This causes his bg to rise again and he later was diagnosed with diabetic ketoacidosis.They placed him back on insulin intravenously and at 16:00 he was released from the hospital.

Manufacturer Narrative

The returned product was evaluated and performed as designed.No kink or bend was observed in the cannula.No defect or deficiency that would result in the cannula to fail to insert correctly or the pump to fail to deliver insulin was found.The customer reported that the cannula was on top of the skin at the infusion site.This condition cannot be confirmed nor excluded through laboratory investigation.

• Brand Name: OMNIPOD INSULIN PUMP
• Type of Device: PUMP, INFUSION, INSULIN
• Manufacturer (Section D): INSULET CORPORATION; bedford MA
• Manufacturer Contact: michael doyle ; 9 oak park dr.; bedford, MA 01730 ; 7814575000
• MDR Report Key: 3760958
• MDR Text Key: 4465024
• Report Number: 3004464228-2014-00464
• 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: Foreign,Consumer,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2015
• Device Model Number: 14000
• Device Catalogue Number: ZXP425
• Device Lot Number: L40805
• Other Device ID Number: 0520896
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/31/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/12/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2013
• 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: 114 YR