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

Model Number 14000

Device Problem Insufficient Information (3190)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912); Seizures (2063)

Event Date 03/28/2014

Event Type  Injury  

Event Description

The customer's mother reported that the pod was activated at 10:44 am on (b)(6) 2014.The customer's blood glucose was 400 mg/dl, and the customer had just eaten 50 grams of carbohydrates, so he bolused 17 units of insulin.At 3:30 pm, the customer has low blood glucose levels and had a seizure.He fell over and was unconscious.He was taken to the er by ambulance.The customer was hospitalized for 48 hours.The doctor was having difficulty bringing the customer's blood glucose level up out of the 30's-40's (mg/dl), so he removed the pod.The customer was treated with iv glucose.He also suffered injuries during his fall and obtained a cracked occiput, 2 small brain contusions, and a small epidural hematoma.The customer has no memory of the event.The pod was discarded.

Manufacturer Narrative

The device was discarded and will not be returned for evaluation.We are unable to determine if any malfunction or other product condition could have contributed to the reported hospitalization and hypoglycemia.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: 3800200
• MDR Text Key: 17386137
• Report Number: 3004464228-2014-00556
• 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: 03/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/01/2015
• Device Model Number: 14000
• Device Catalogue Number: ZXP425
• Device Lot Number: L40887
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/31/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2014
• 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 Outcome(s): Hospitalization
• Patient Age: 22 YR