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

Model Number 19191

Device Problem Insufficient Information (3190)

Patient Problems Fainting (1847); Hypoglycemia (1912)

Event Date 02/28/2020

Event Type  Injury  

Manufacturer Narrative

The product was not returned for evaluation.We are unable to determine if any product malfunction or other product condition could have contributed to the reported hypoglycemia and er visit.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 35.Warning: test results below 3.9 mmol/l mean low blood glucose (hypoglycemia).Test results greater than 13.9 mmol/l mean high blood glucose (hyperglycemia).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 9 / page 121.Hypoglycemia can occur even when a pod is working properly.Never ignore the signs of low blood glucose (no matter how mild).If left untreated, severe hypoglycemia can cause seizures or lead to unconsciousness.If you suspect that your blood glucose level is low, check your bg level to confirm.Living with diabetes 9 / page 123.Frequent blood glucose checks are the key to avoiding potential problems.Detecting low blood glucose early lets you treat it before it becomes a problem.

Event Description

It was reported that the patient visited the emergency room (er) due to low blood glucose (bg) levels of 50 mg/dl, while wearing the pod on the arm between 4 and 24 hours, ending passing out on the street.At the hospital, the patient was treated with bepanthen and a glucose injection (glucagon hypo-kit glucagon).

• 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: 9779213
• MDR Text Key: 181936556
• Report Number: 3004464228-2020-02974
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 20385081120033
• UDI-Public: (01)20385081120033(11)190802(17)210208(10)L45035
• 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: 02/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/08/2021
• Device Model Number: 19191
• Device Catalogue Number: ZXP425
• Device Lot Number: L45035
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2019
• 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): Required Intervention
• Patient Age: 38 YR