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

Model Number 18900-5C

Device Problem Reset Problem (3019)

Patient Problems Headache (1880); Hyperglycemia (1905); Vomiting (2144)

Event Date 02/28/2020

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 hyperglycemia.Lot release records were reviewed and the product lot met all acceptance criteria.Omnipod insulin management system ¿ user guide.Model: ent450.17845-5c-aw rev a 10/17.Checking your blood glucose 4 / page 36.Warning: test results greater than 13.9 mmol/l mean high blood glucose (hyperglycemia).Warning: if you get results below 3.9 mmol/l or above 13.9 mmol/l, but do not have symptoms of hypoglycemia or hyperglycemia (see "living with diabetes" on page 117), repeat the test.If you have symptoms or continue to get results that fall below 3.9 mmol/l or above 13.9 mmol/l, follow the treatment advice of your healthcare provider.Living with diabetes 11 / page 129.Warning: if left untreated, dka can cause breathing difficulties, shock, coma, and eventually death.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.Checking your blood glucose 4 / page 44.Warning: ¿low¿ or ¿high¿ blood glucose readings can indicate a potentially serious condition requiring immediate medical attention.If left untreated, this situation can quickly lead to diabetic ketoacidosis (dka), shock, coma, or death.Checking your blood glucose 4 / page 36: you should perform a control solution test when: you suspect that the built-in bg meter or test strips are not working properly.You think your bg readings are not accurate or are not consistent with how you feel.You drop or damage your pdm or expose it to liquids.Your healthcare provider advises you to do so.Living with diabetes 11 / pages 118: warning: keep an emergency kit with you at all times to quickly respond to any diabetes emergency.The kit should include: several new, sealed pods, extra new pdm batteries (at least two aaa alkaline), a vial of rapid-acting u-100 insulin, syringes or pens for injecting insulin, blood glucose test strips, additional blood glucose meter, ketone test strips, lancing device and lancets, glucose tablets or another fast-acting source of carbohydrate, alcohol prep swabs, instructions from your healthcare provider about how much insulin to inject if delivery from the pod is interrupted.Living with diabetes 11 / pages 119.When packing for travel, take more supplies than you think you¿ll need.Be sure to include an additional blood glucose meter and written prescriptions for all medications and supplies.Generic medications may be easier to find than brand names outside your country.

Event Description

It was reported that the patient was hospitalized due to "high" blood glucose (bg) levels, vomiting, headache and lack of appetite with history as follows: (b)(6).The patient used a manual insulin injection of 4 units with a pen and increased the basal rate on the omnipod personal diabetes manager (pdm) at home, but the bg levels did not decrease.At the hospital, the patient was treated with insulin injections utilizing a pen by the health care provider (hcp) and given paracetamol for the headache.The pdm will also reset on it own.

• Brand Name: OMNIPOD INSULIN MANAGEMENT SYSTEM
• Type of Device: PUMP, INFUSION, INSULIN
• Manufacturer (Section D): INSULET CORPORATION; 100 nagog park; acton MA 01720
• Manufacturer (Section G): INSULET CORPORATION; 100 nagog park; acton MA 01720
• Manufacturer Contact: jordan biswurm ; 100 nagog park; acton, MA 01720 ; 9786007000
• MDR Report Key: 9788008
• MDR Text Key: 189981332
• Report Number: 3004464228-2020-03217
• Device Sequence Number: 1
• Product Code: LZG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162296
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/02/2020

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 18900-5C
• Device Catalogue Number: ENT450
• Device Lot Number: L60515
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/02/2020
• Initial Date FDA Received: 03/04/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 11 YR