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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
Device Problem Low Test Results
Event Date 11/14/2013
Event Type  Death  
Manufacturer Narrative

The pdm was not returned for evaluation. We are unable to determine if any device malfunction could have contributed to the reported inaccurate low test results, diabetic ketoacidosis and death. Qualification records were reviewed and the product lot met all acceptance criteria.

 
Event Description

On (b)(6) 2010 abbot diabetes care informed insulet corp of a report received from a physician. His pt was receiving erroneously low readings using the omnipod insulin mgmt sys integrated freestyle blood glucose meter with freestyle lite test strips, which are not cleared for use with omnipod. He reported the pt had diabetic ketoacidosis (dka) and passed away. In a follow up call after reviewing the patient's meter records the doctor reported that in the 48 hours before passing the readings were all less than 72 mg/dl and in the last 12 hours they were between 60 mg/dl and 70 mg/dl. The pt passed away at home, unattended; the autopsy reported cause of death as dka. He performed a control solution test on the patient's meter and strips in his office and received a reading of 23 mg/dl. A subsequent control solution test with another set of strips was reportedly within range. It is unk what type of control solution he used. He also stated that he was aware of the off-label test strip use and that the pt had been using them for 3 years. The decedent's family's attorney later contacted insulet corp. She confirmed the cause and place (dorm room) of death. She stated the date of death and that the deceased was found wearing a pod. She was unsure if decedent was on any other medications and unaware of any other illnesses. She stated the endocrinologist had reported the event to fda.

 
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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 Key3644443
Report Number3004464228-2014-00159
Device Sequence Number1
Product CodeLZG
Report Source Manufacturer
Source Type Other,Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 01/10/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/13/2014
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 NumberUST200
Device LOT NumberL50064
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received01/10/2014
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: 02/13/2014 Patient Sequence Number: 1
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