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U.S. Department of Health and Human Services

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

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INSULET CORPORATION OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN Back to Search Results
Model Number 14000
Device Problem Insufficient Information
Event Date 07/04/2016
Event Type  Death  
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.

 
Manufacturer Narrative

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

 
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Brand NameOMNIPOD INSULIN PUMP
Type of DevicePUMP, 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 Key5848241
Report Number3004464228-2016-02222
Device Sequence Number1
Product CodeLZG
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
Date FDA Received08/04/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Device MODEL Number14000
Device Catalogue NumberZXP425
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/05/2016
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 TREATMENT DATA
Date Received: 08/04/2016 Patient Sequence Number: 1
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