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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 13100-2B
Event Date 03/30/2011
Event Type  Death  
Event Description

The customer's wife had contacted her husband's clinical services manager to report that he had passed away. He was "missing for one week" before being found in a lake near his home. " though the cause of his passing was not conclusive at the time of the report, it was due to "either hypoglycemia or hyperglycemia. " the customer had been using the omnipod system at the time of the event; though she "wasn't necessarily blaming the product" for the incident, she wanted to look into it further to "prevent this from happening to anyone else. " (she has been speaking to a forensic pathologist" and may have an investigator look further into the pdm. Pod. ") presently, she has possession of the pdm; she has "not touched it and wants to hold on to it. " (it is unk whether the device had been submerged in water. ) the pod was not returned to her; its whereabouts are unk at this time. Due to her extreme emotional state and the fact that she said "she does not want to be contacted at this time by insulet," a request for the pdm to be returned for eval has not been made. If future circumstances deem it appropriate that she be contacted, the pdm will be requested at that time. Because of the sensitive nature of this case, all pertinent info surrounding the incident could not be obtained at this time. Insulet shall take all appropriate measures to obtain as much info as possible regarding details of the event and the devices involved (including investigations of the pod and pdm, if possible). A f/u report shall be submitted if and when add'l info is learned.

 
Manufacturer Narrative

Neither the pod nor the pdm involved in this incident have been returned for eval - we are unable to determine whether any malfunction of the omnipod system may have caused or contributed to the event. The location of the pod is presently unk; the pdm is in the possession of the customer's wife but will not be returned for investigation at this time. Out of consideration for her request not to be contacted, insulet has not asked for the pdm to be returned. No conclusion can be drawn. Limited info about this event was available at the time of this submission. Given the sensitive nature of the incident and her extreme emotional state, insulet has decided not to contact the customer's wife for add'l info at this time. A request for the pdm to be returned for investigation and for further details about the incident shall be made if future circumstances deem it appropriate. A f/u report will be submitted if and when add'l incident or device info is learned. A review of lot qualification records was unable to be performed as no pod or pdm lot numbers were provided. Note: the user had been one of insulet's first customer's who had been on the omnipod system since (b)(6) 2006. Though he experienced issues from time to time, he reportedly "did quite well on the system. " his issues with the system were known to insulet, as he spoke with his clinical services manager (csm) as well as product support" on a regular basis over the past five years. " in addition, he had met with his csm a few years ago "to troubleshoot and review his technique. ".

 
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Brand NameOMNIPOD INSULIN PUMP
Type of DevicePUMP, INFUSION, INSULIN
Manufacturer (Section D)
INSULET CORPORATION
bedford MA
Manufacturer Contact
ruthann depietro
9 oak park dr.
bedford , MA 01730
7814575000
MDR Report Key2149043
Report Number3004464228-2011-00299
Device Sequence Number1
Product CodeLZG
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 05/25/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/24/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Device MODEL Number13100-2B
Device Catalogue NumberUNAVAILABLE
Device LOT NumberUNAVAILABLE
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received05/25/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 06/24/2011 Patient Sequence Number: 1
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