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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 No Information
Event Date 01/22/2014
Event Type  Injury  
Event Description

The pt's mother reported on (b)(6) 2014 her son was having a seizure and was convulsing so she called 911. Upon the emergency medical technician's arrival he was found to be unresponsive so they checked his blood glucose it was reading 24 mg/dl. They treated hi with a shot of glucagon and he became responsive. She also stated she gave him 12 juice boxes and a sandwich. He did not 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. No product lot number was reported therefore no qualification records were reviewed.

 
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Brand NameOMNIPOD INSULIN PUMP
Type of DevicePUMP, INFUSION, INSULIN
Manufacturer (Section D)
INSULET CORPORATION
bedford MA
Manufacturer Contact
michael doyle
9 oak park dr.
bedford , MA 01730
7814575000
MDR Report Key3732958
Report Number3004464228-2014-00389
Device Sequence Number1
Product CodeLZG
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial
Report Date 02/25/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/26/2014
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
Date Manufacturer Received02/25/2014
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: 03/26/2014 Patient Sequence Number: 1
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