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

Model Number 14810-5S

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Hypoglycemia (1912)

Event Date 02/16/2015

Event Type  Death  

Event Description

A doctor in (b)(6) reported that on the morning of (b)(6) 2015, the pt was at a tobacco shop where a colleague noticed that the users face was faded and sweaty.He told his colleague that he was not feeling well and believe it was because of the fish he has consumed on (b)(6) 2015.His partner called him later that dat and explained to her the same thing as he did to his colleague.By the next day his partner called him again and there was no answer so she thought that the must have forgotten his phone again at work.By monday ((b)(6) 2015) has was not seen at work and he was not able to be reached by phone.The police was then called and upon their arrival at his house he was found dead in a chair in the living room.The pod was found beeping; it was teared off the body and laid next to the corpse.The last documented blood glucose reading was noted in the morning of (b)(6) his bg was reading of 162 mg/dl and the pod was going to be expired that morning but it was not clear why he did not change out the pod as usual.During an autopsy it was found that he presumably died on saturday evening ((b)(6)) and that he has experienced hyperglycemia but it was not sure if that was the cause of his death.

Manufacturer Narrative

The product was not returned for eval.We are unable to determine if any product defect could have contributed to the pt's hypoglycemia/death.No qualification records could be reviewed because no product lot number was reported.

• Brand Name: OMNIPOD INSULIN PUMP
• Type of Device: PUMP, INFUSSION, INSULIN
• Manufacturer (Section D): INSULET CORPORATION; billerica MA
• Manufacturer Contact: michael doyle ; 600 technology park dr; ste 200; billerica, MA 01821 ; 9786007000
• MDR Report Key: 4577978
• MDR Text Key: 21727351
• Report Number: 3004464228-2015-00041
• 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: Foreign,Consumer,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 14810-5S
• Device Catalogue Number: ZXY425
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2015
• 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