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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 Difficult or delayed activation
Event Date 08/26/2014
Event Type  Malfunction  
Event Description

Time: 1:50 pm, blood glucose (mg/dl): 283. Time: 3:00 p. M, blood glucose (mg/dl): 324. Time 3:55pm, blood glucose (mg/dl): 294 - pod deactivated. The customer's mother reported that the needle deployed 10 minutes after it was supposed to.

 
Manufacturer Narrative

The device was not returned for evaluation. We are unable to confirm the reported needle mechanism failure to fire and properly deploy 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
billerica MA
Manufacturer Contact
michael doyle
600 technology park dr. suite 200
billerica , MA 01821
9786007000
MDR Report Key4189290
Report Number3004464228-2014-01459
Device Sequence Number1
Product CodeLZG
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial
Report Date 09/02/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/30/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Lay User/Patient
Device EXPIRATION Date08/01/2015
Device MODEL Number14000
Device Catalogue NumberZXP425
Device LOT NumberL40929
OTHER Device ID Number0013490
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received09/02/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/01/2014
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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