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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 Unintended Movement
Event Date 03/07/2014
Event Type  Injury  
Event Description

The customer's parent reported on (b)(6) their (b)(6) autistic son was hospitalized and his blood glucose, carbohydrate intake and insulin history is as follows. At 11:00 he was vomiting so they called his doctor who advised them to take him to the emergency room. At 13:00 he was hospitalized in the intensive care unit and was placed on an intravenous therapy of insulin. The pod was removed, they then noticed the cannula was folded over and it was totally dried. The next morning (b)(6) his bg was reading 119 mg/dl and the hospital staff accidently disconnected the iv of insulin and the left the iv of glucose on instead. This causes his bg to rise again and he later was diagnosed with diabetic ketoacidosis. They placed him back on insulin intravenously and at 16:00 he was released from the hospital.

 
Manufacturer Narrative

The returned product was evaluated and performed as designed. No kink or bend was observed in the cannula. No defect or deficiency that would result in the cannula to fail to insert correctly or the pump to fail to deliver insulin was found. The customer reported that the cannula was on top of the skin at the infusion site. This condition cannot be confirmed nor excluded through laboratory investigation.

 
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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 Key3760958
Report Number3004464228-2014-00464
Device Sequence Number1
Product CodeLZG
Report Source Manufacturer
Source Type Foreign,Consumer,Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 03/12/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/10/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Device EXPIRATION Date06/30/2015
Device MODEL Number14000
Device Catalogue NumberZXP425
Device LOT NumberL40805
OTHER Device ID Number0520896
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer03/31/2014
Is The Reporter A Health Professional? No
Date Manufacturer Received03/12/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/01/2013
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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