MAUDE Adverse Event Report: INSULET CORPORATION OMNIPOD INSULIN PUMP; PUMP, INFUSION, INSULIN

Model Number 14000

Device Problem Insufficient Information (3190)

Patient Problems Hyperglycemia (1905); Diabetic Ketoacidosis (2364); Irritability (2421)

Event Date 10/14/2017

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation.We are unable to determine if any product condition could have contributed to the reported hospitalization and diabetic ketoacidosis.No lot release records were reviewed, as the product lot number was not provided.Omnipod insulin management system ¿ user guide model: ust400 14421-aw rev h 01/16 checking your blood glucose 7 / page 96 warning: test results greater than 250 mg/dl mean high blood glucose (hyperglycemia).Warning: if you get results below 70 mg/dl or above 250 mg/dl, but do not have symptoms of hypoglycemia or hyperglycemia, repeat the test.If you have symptoms or continue to get results that fall below 70 mg/dl or above 250 mg/dl, follow the treatment advice of your healthcare provider.Living with diabetes 9 / page 119 warning: if left untreated, dka can cause breathing difficulties, shock, coma, and eventually death.Advises: the easiest and most reliable way to avoid dka is by checking your blood glucose at least 4¿6 times a day.Routine checks allow you to identify and treat high blood glucose before dka develops.

Event Description

The patient reported that he was wearing the pod for longer than 48 hours when it caused him to go into diabetic ketoacidosis (dka).On the second day, he was supplementing by giving himself manual injections and his levels still did not come down.He felt irritable and his breathing, as well as heart rate, was irregular.The patient¿s blood glucose read 389mg/dl at 2:00am and at 6:00am he went to the hospital (on the third day of wear) since he could not drink water at the time (tried taking a tablespoon of water but could not).The patient spent a day in the hospital.He was diagnosed with dka, had fractured ribs, and an infection in his jaw.The patient expressed that he did not feel the dka was a pod issue, but an issue that could have been caused by his jaw infection and the broken rib he had.Treatment included insulin through an iv and administering fluid (saline and sodium chloride) into his body.No changes were made to the patient¿s insulin doses or setting as a results of the event.When the pod was removed, he could smell insulin and there was liquid inside of the device.The pod was thrown away at the hospital.

• Brand Name: OMNIPOD INSULIN PUMP
• Type of Device: PUMP, INFUSION, INSULIN
• Manufacturer (Section D): INSULET CORPORATION; 600 technology park drive; suite 200; billerica MA 01821
• Manufacturer (Section G): INSULET CORPORATION; 600 technology park drive; suite 200; billerica MA 01821
• Manufacturer Contact: derek sammarco ; 600 technology park drive; suite 200; billerica, MA 01821 ; 9786007000
• MDR Report Key: 7329732
• MDR Text Key: 102066680
• Report Number: 3004464228-2018-01423
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 20385081120002
• UDI-Public: (01)20385081120002
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122953
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 14000
• Device Catalogue Number: ZXP425
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/12/2018
• Initial Date FDA Received: 03/11/2018
• 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 Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 53 YR