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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 08/06/2014
Event Type  No Answer Provided  
Event Description

An email communication was received to report that on (b)(6) 2014, before going to bed, the patient's blood glucose reading was 75 mg/dl and he had not had anything to eat for dinner. On (b)(6) 2014, at 5:00 am, he woke up and took a shower. During his shower, he fainted; foam was coming out of his mouth and his nose was bleeding. His mother called for the paramedics and upon their arrival, his bg was reading 29 mg/dl. He was treated with glucose intravenously and did not have to go to the hospital.

 
Manufacturer Narrative

The product was not returned for evaluation. We are unable to determine if any product malfunction or other product condition could have contributed to the reported hypoglycemia and the emergency dispatcher was called. 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
billerica MA
Manufacturer Contact
michael doyle
600 technology park dr.
suite 200
billerica , MA 01821
9786007000
MDR Report Key4115529
Report Number3004464228-2014-01309
Device Sequence Number1
Product CodeLZG
Report Source Manufacturer
Source Type Consumer
Type of Report Initial
Report Date 08/07/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/04/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Device EXPIRATION Date05/01/2015
Device MODEL Number14000
Device Catalogue NumberZXP425
Device LOT NumberL40753
OTHER Device ID Number1454248
Was Device Available For Evaluation? No
Date Manufacturer Received08/07/2014
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured11/01/2013
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: 09/04/2014 Patient Sequence Number: 1
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