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

Model Number 14000

Device Problem Insufficient Information (3190)

Patient Problems Fainting (1847); Hypoglycemia (1912)

Event Date 08/06/2014

Event Type  No Answer Provided  

Event Description

An email communication was received to report that on (b)(6) 2014, before going to bed, the patient's blood glucose reading was 75 mg/dl and he had not had anything to eat for dinner.On (b)(6) 2014, at 5:00 am, he woke up and took a shower.During his shower, he fainted; foam was coming out of his mouth and his nose was bleeding.His mother called for the paramedics and upon their arrival, his bg was reading 29 mg/dl.He was treated with glucose intravenously and did not have to go to the hospital.

Manufacturer Narrative

The product was not returned for evaluation.We are unable to determine if any product malfunction or other product condition could have contributed to the reported hypoglycemia and the emergency dispatcher was called.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; billerica MA
• Manufacturer Contact: michael doyle ; 600 technology park dr.; suite 200; billerica, MA 01821 ; 9786007000
• MDR Report Key: 4115529
• MDR Text Key: 4834979
• Report Number: 3004464228-2014-01309
• 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
• Type of Report: Initial
• Report Date: 08/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/01/2015
• Device Model Number: 14000
• Device Catalogue Number: ZXP425
• Device Lot Number: L40753
• Other Device ID Number: 1454248
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/07/2014
• Date Device Manufactured: 11/01/2013
• 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 Outcome(s): Hospitalization