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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 01/30/2014
Event Type  Injury  
Event Description

The customer's mother reported that the customer was hospitalized with diabetic ketoacidosis (dka) on (b)(6) 2014. The customer was vomiting and had low blood pressure. The customer's mother also reported that the customer had swelling on parts of her face and body. She was treated with an insulin cup. The customer was hospitalized for 36 hours. The pod was thrown away at the hospital. (b)(6).

 
Manufacturer Narrative

The device was not returned for evaluation. We are unable to determine if any malfunction or other product condition could have contributed to the reported hospitalization with dka. Lot qualification records were reviewed and the product lot met all acceptance criteria.

 
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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 Key3674359
Report Number3004464228-2014-00263
Device Sequence Number1
Product CodeLZG
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial
Report Date 02/06/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/05/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Device EXPIRATION Date04/01/2015
Device MODEL Number14000
Device Catalogue NumberZXP425
Device LOT NumberL40641
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received02/06/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/01/2013
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 03/05/2014 Patient Sequence Number: 1
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