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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 12/01/2013
Event Type  Injury  
Event Description

An insulet clinical services manager reported that the pt was at school when he felt like he was being poked at the infusion site and upon inspection he noticed the cannula was not inserted into the infusion site. He did not tell the school nurse or call his mother and he continued to wear the pod. When he returned home from school his blood glucose was extremely high so his parent gave him multiple bolus correction (exact bg level and insulin dosage was not provided) with no improvement to his bg levels. He was vomiting so they checked for ketones and they were present. The parent called his physician who advises them to take him to the emergency room. At the er he was diagnosed for diabetic ketoacidosis.

 
Manufacturer Narrative

The product was not returned for eval. We are unable to confirm any product malfunction or other product condition to have contributed to the pt's ketoacidosis and er visit. The user reported a dislodged cannula. This condition would interrupt insulin delivery and contribute to hyperglycemia if it occurred. 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 Key3609084
Report Number3004464228-2014-00108
Device Sequence Number1
Product CodeLZG
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial
Report Date 12/30/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/27/2014
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? Yes
Date Manufacturer Received12/30/2013
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: 01/27/2014 Patient Sequence Number: 1
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