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

Model Number 14000

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Myocardial Infarction (1969)

Event Date 07/04/2016

Event Type  Death  

Manufacturer Narrative

No product was returned for evaluation.No qualification records were reviewed; no product lot number was reported.

Event Description

The patient's wife reported that she woke up and noticed that her husband was not breathing so she called 911.Upon their arrival they told her that he had passed away before they got there.She also reported the night before he was sweating really badly so she checked his blood glucose it read 145 mg/dl.She stated that she wanted to take him to the doctor but he told her "no" and that he was fine.There was no report of a specific device malfunction however, we cannot rule out any allegation of device involvement at this time.Pending further investigation.

Manufacturer Narrative

The patient's wife called back to report the cause of death on the death certificate was a heart attack.She also mentioned that he was taking medication for his blood pressure and kidney.No other medical issues noted.

• Brand Name: OMNIPOD INSULIN PUMP
• Type of Device: PUMP, INFUSION, INSULIN
• Manufacturer (Section D): INSULET CORPORATION; 600 technology park drive; suite 200; billerica MA 01821
• Manufacturer (Section G): INSULET CORPORATION; 600 technology park drive; suite 200; billerica MA 01821
• Manufacturer Contact: derek sammarco ; 600 technology park drive; suite 200; billerica, MA 01821 ; 9786007000
• MDR Report Key: 5848241
• MDR Text Key: 51222067
• Report Number: 3004464228-2016-02222
• Device Sequence Number: 1
• Product Code: LZG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122953
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 07/04/2016

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: 07/05/2016
• Initial Date FDA Received: 08/04/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/12/2016
• 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): Death
• Patient Age: 33 YR