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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 14810-5C
Device Problem Device Dislodged or Dislocated
Event Date 10/15/2013
Event Type  Death  
Event Description

The patient's nurse/trainer reported that the patient was dead and her family is very unhappy. They said the pump had never worked but that this was due to the pods continually falling off. They have directed a lot of their concerns at the hospital training team as they felt the patient's blood glucose levels should have been monitored more closely. The nurse; however, stated that the patient had never expressed any concerns about the pump or her bgs during follow up calls after training and so she could not do anything as she was unaware. The nurse said that had she known the pods kept falling off, she would have recommended various products that she knows would have helped them stick better. Looking at the patient's history records, the nurse feels that the patient's bg levels were going high (when the pods fell off) and then she was correcting with an insulin pen and experiencing hypoglycemia. No more details available at the moment. The nurse will inform us when the post mortem is back.

 
Manufacturer Narrative

The device was not returned for evaluation. We are unable to determine if any product defect could have contributed to the pod adhesion issues and the patient's death. No qualification records could be reviewed because no product lot number was reported.

 
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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 Key3495620
Report Number3004464228-2013-01391
Device Sequence Number1
Product CodeLZG
Report Source Manufacturer
Source Type Foreign,Consumer,Distributor
Type of Report Initial
Report Date 10/21/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/19/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Device MODEL Number14810-5C
Device Catalogue NumberZXY425
Was Device Available For Evaluation? No
Date Manufacturer Received10/21/2013
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: 11/19/2013 Patient Sequence Number: 1
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