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

Model Number 14000

Device Problem Insufficient Information (3190)

Patient Problems Hyperglycemia (1905); Neuropathy (1983); Depression (2361); Diabetic Ketoacidosis (2364)

Event Date 01/31/2019

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, 17845-5a-aw rev b 09/17.Checking your blood glucose: chapter 4/page 36.Warnings: test results below 70 mg/dl mean low blood glucose (hypoglycemia).Test results greater than 250 mg/dl mean high blood glucose (hyperglycemia).If you get results below 70 mg/dl or above 250 mg/dl, but do not have symptoms of hypoglycemia or hyperglycemia (see "living with diabetes" on page 115), 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.Checking your blood glucose: chapter 4/page 42.Warning: blood glucose readings that are especially low or high can indicate potentially serious condition requiring immediate medical attention.If left untreated, this situation can quickly lead to diabetic ketoacidosis (dka), shock, coma, or death.Living with diabetes: chapter 11/page 119.Avoid lows, highs, and dka: you can avoid most risks related to using the omnipod® system by practicing proper techniques and by acting promptly at the first sign of hypoglycemia, hyperglycemia, or diabetic ketoacidosis.The easiest and most reliable way to avoid these conditions is to check your blood glucose often.Living with diabetes: chapter 11/page 126.Warnings: if left untreated, dka can cause breathing difficulties, shock, coma, and eventually death.If you need emergency attention, ask a friend or family member to take you to the emergency room or call an ambulance.Do not drive yourself.To avoid dka: 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

It was reported that the patient had been hospitalized with diabetic ketoacidosis (dka).The patient's blood glucose levels reached 1000 mg/dl while wearing the pod between 24 and 36 hours (abdomen).Patient's doctor made changes to her basal settings.Symptoms reported include acute diabetic ketoacidocis, chronic diabetic neuropathy, hyperlipidemia, primary hyperthyroidism, osteoporosis, general depression, acute eusdeohypoaeremi and leukocytosis.The patient was treated with intravenous fluids and injections.The patient underwent an ekg, a stint in the heart and an x-ray on her knee.Customer does not have this pod with her it was taken off 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: 8439726
• MDR Text Key: 139437566
• Report Number: 3004464228-2019-02270
• 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: Other
• Type of Report: Initial
• Report Date: 02/24/2019

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
• Initial Date Manufacturer Received: 02/24/2019
• Initial Date FDA Received: 03/21/2019
• 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: 61 YR