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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 Deployment issue
Event Date 03/12/2014
Event Type  Injury  
Manufacturer Narrative

The product was not returned for evaluation. We are unable to confirm the reported failure of the needle mechanism to fire and deploy the cannula or to determine its root cause or to determine if it could have contributed to the reported hyperglycemia and hospitalization. Qualification records were reviewed and the product lot met all acceptance criteria.

 
Event Description

The patient's mother reported on (b)(6) 2014 10:44 pm her daughter activated a new pod. At 2:30 pm, she was throwing up and they decided to take her to the hospital. Upon arrival, she was placed on an intravenous therapy and she was given 5mg of zofen. At 9:22pm, the pod was deactivated and there was no cannula coming out of the pod. The cannula looks as if it had never deployed into the infusion site.

 
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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 Key3763359
Report Number3004464228-2014-00453
Device Sequence Number1
Product CodeLZG
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial
Report Date 03/12/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/08/2014
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 NumberL40748
OTHER Device ID Number0330458
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received03/12/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 04/08/2014 Patient Sequence Number: 1
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