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U.S. Department of Health and Human Services

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

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INSULET CORPORATION OMNIPOD INSULIN PUMP PUMP, INFUSSION, INSULIN Back to Search Results
Model Number 14810-5S
Device Problem No Information
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.

 
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Brand NameOMNIPOD INSULIN PUMP
Type of DevicePUMP, 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 Key4577978
Report Number3004464228-2015-00041
Device Sequence Number1
Product CodeLZG
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 Received02/27/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Device MODEL Number14810-5S
Device Catalogue NumberZXY425
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received02/17/2015
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 TREATMENT DATA
Date Received: 02/27/2015 Patient Sequence Number: 1
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