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

Model Number 14000

Device Problem Insufficient Information (3190)

Patient Problems Hyperglycemia (1905); Vomiting (2144); Diabetic Ketoacidosis (2364)

Event Date 01/30/2014

Event Type  Injury  

Event Description

The customer's mother reported that the customer was hospitalized with diabetic ketoacidosis (dka) on (b)(6) 2014.The customer was vomiting and had low blood pressure.The customer's mother also reported that the customer had swelling on parts of her face and body.She was treated with an insulin cup.The customer was hospitalized for 36 hours.The pod was thrown away at the hospital.(b)(6).

Manufacturer Narrative

The device was not returned for evaluation.We are unable to determine if any malfunction or other product condition could have contributed to the reported hospitalization with dka.Lot 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 CORPORATION; bedford MA
• Manufacturer Contact: michael doyle ; 9 oak park dr.; bedford, MA 01730 ; 7814575000
• MDR Report Key: 3674359
• MDR Text Key: 4298245
• Report Number: 3004464228-2014-00263
• 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: 02/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/01/2015
• Device Model Number: 14000
• Device Catalogue Number: ZXP425
• Device Lot Number: L40641
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2013
• Is the Device Single Use?: No
• 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: 11 YR