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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 11200
Event Date 09/07/2011
Event Type  Death  
Event Description

The (b)(6) medical examiner's office called on (b)(6) 2011 to report that a customer was found deceased in his home. He was found wearing a pod and a dexcom cgm. The medical examiner's office was contacted again on (b)(6) 2011 and confirmed on (b)(6) 2011 that "the manner of death is atherosclerotic disease with other significant diseases which include type 1 diabetes, dyslipidemia, obesity and cardiomegaly. " the medical examiner's office was in communication with the wife of the deceased and she could not find the pdm and therefore only the pod was returned for eval.

 
Manufacturer Narrative

The returned pod was evaluated. The piezo was tested and found to emit an audible alarm tone which indicates the alarm was functioning properly. The pulse width data log from the pod could not be retrieved to assess how the drive function operated. The fluid path was free of internal occlusions, allowing for a free flow of insulin. No signs of internal leakage were found. The occlusion sensor and needle/insertion mechanism functioned as expected. Based on this eval, no malfunction was found that would have caused restricted or interrupted insulin delivery. Product lot qualification records for the returned pod were reviewed and determined to have 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 drive
bedford , MA 01730
7814575000
MDR Report Key2287936
Report Number3004464228-2011-00591
Device Sequence Number1
Product CodeLZG
Report Source Manufacturer
Source Type Other,Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 09/07/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/07/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Device EXPIRATION Date04/01/2013
Device MODEL Number11200
Device Catalogue NumberZXP325
Device LOT NumberL30544
OTHER Device ID Number122424
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer09/30/2011
Is The Reporter A Health Professional? Yes
Date Manufacturer Received09/07/2011
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/01/2011
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: 10/07/2011 Patient Sequence Number: 1
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