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

Model Number 14000

Device Problem Insufficient Information (3190)

Patient Problems Vomiting (2144); Diabetic Ketoacidosis (2364)

Event Date 11/24/2013

Event Type  Injury  

Event Description

The patient's mother reported on (b)(6) 2013 her daughter activated a new pod.She was throwing up for a total of 6 hours, so she called the doctor who advised her to go to the hospital.The pod was deactivated and discarded.She was able to activate a new pod.She drove her daughter to the hospital and it was about an hour away.Upon arrival, she was admitted for mild diabetic ketoacidosis.She was treated with a manual injection of insulin (exact dosage was not provided) and was given fluids.She stayed in hospital for a total of 24 hours.

Manufacturer Narrative

The product was not returned for evaluation.We are unable to confirm any product malfunction or other product condition to have contributed to the patient's ketoacidosis and hospitalization.No product lot number was reported; therefore, no qualification records were reviewed.

• 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: 3587704
• MDR Text Key: 4136922
• Report Number: 3004464228-2014-00004
• 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: 12/05/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 14000
• Device Catalogue Number: ZXP425
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/05/2013
• Initial Date FDA Received: 01/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Hospitalization
• Patient Age: 13 YR