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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 12/23/2013
Event Type  Malfunction  
Event Description

The customer's mother reported that had to remove the pod due to the customer's high blood sugar. The pdm read high (>500 mg/dl). The customer's mother stated that when pod was removed, it was noticed that the cannula never fully deployed. The pod was worn between 2-3 hours.

 
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. 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 Key3795289
Report Number3004464228-2014-00078
Device Sequence Number1
Product CodeLZG
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial
Report Date 12/23/2013
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/22/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Lay User/Patient
Device EXPIRATION Date04/01/2015
Device MODEL Number14000
Device Catalogue NumberZXP425
Device LOT NumberL40657
OTHER Device ID Number0014718
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received12/23/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/01/2013
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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