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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 11/24/2013
Event Type  Injury  
Manufacturer Narrative

The product was not returned for evaluation. We are unable to confirm any product malfunction or other product condition to have contributed to the patient's ketoacidosis and hospitalization. No product lot number was reported; therefore, no qualification records were reviewed.

 
Event Description

The patient's mother reported on (b)(6) 2013 her daughter activated a new pod. She was throwing up for a total of 6 hours, so she called the doctor who advised her to go to the hospital. The pod was deactivated and discarded. She was able to activate a new pod. She drove her daughter to the hospital and it was about an hour away. Upon arrival, she was admitted for mild diabetic ketoacidosis. She was treated with a manual injection of insulin (exact dosage was not provided) and was given fluids. She stayed in hospital for a total of 24 hours.

 
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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 Key3587704
Report Number3004464228-2014-00004
Device Sequence Number1
Product CodeLZG
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial
Report Date 12/05/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/03/2014
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 Received12/05/2013
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: 01/03/2014 Patient Sequence Number: 1
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