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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 10/26/2014
Event Type  Injury  
Manufacturer Narrative

The device was not returned for evaluation. We are unable to determine if any product condition could have contributed to the reported er visit for hyperglycemia. No lot qualification records were reviewed, as the product lot number was not provided.

 
Event Description

The customer's mother reported that the customer was taken to the er for a second time that day. The customer had a blood glucose in the 400-500 mg/dl range and had been vomiting all day. The customer was treated for nausea and given a prescription for ondansetron. The mother treated the high bg with a manual injection of insulin.

 
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Brand NameOMNIPOD INSULIN PUMP
Type of DevicePUMP, INFUSION, INSULIN
Manufacturer (Section D)
INSULET CORPORATION
billerica MA
Manufacturer Contact
michael doyle
600 technology park drive
suite 200
billerica , MA 01821
9786007000
MDR Report Key4377205
Report Number3004464228-2014-01926
Device Sequence Number1
Product CodeLZG
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial
Report Date 11/18/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/18/2014
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 Received11/18/2014
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: 12/18/2014 Patient Sequence Number: 1
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