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

Model Number 19191

Device Problem Insufficient Information (3190)

Patient Problems Headache (1880); Hyperglycemia (1905); Urinary Tract Infection (2120); Weakness (2145); Diabetic Ketoacidosis (2364)

Event Date 06/26/2020

Event Type  Injury  

Manufacturer Narrative

According to the complainant the device is not being returned for investigation.We are unable to determine if any product condition could have contributed to the reported hospitalization hyperglycemia and diabetic ketoacidosis.Lot release records were reviewed and the product lot met all acceptance criteria.For your reference, insulet modified our internal investigation finding codes effective 25 may 2020 as part of an effort to improve the classification of findings to improve the power of trending data and make the findings more intuitive.The new findings codes will use the system of finding category (e.G.Hardware component), followed by the affected component (e.G.Needle), followed by the condition (e.G.Bent).Therefore you may notice findings that appear to be new or different but in fact are just renamed for improved data value.Insulet would be happy to explain any mapping of the old to new finding codes if you have any questions.

Event Description

It was reported that the patient was taken to the emergency room (er) via ambulance due to diabetic ketoacidosis (dka) high blood glucose (bg) levels exceeding 400 mg/dl, weakness, and severe headaches, while wearing the pod on the arm between 36 and 48 hours.Manual insulin injections using pens were administered at home but the bg levels did not decrease.At the hospital, the patient was placed on infusion of insulin and fluids and given a prescription of antibiotics to treat a urinary infection found.

• 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: 10270581
• MDR Text Key: 198706043
• Report Number: 3004464228-2020-11193
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 20385081120033
• UDI-Public: (01)20385081120033(11)191205(17)210605(10)L45331
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192659
• 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: 07/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/05/2021
• Device Model Number: 19191
• Device Catalogue Number: ZXP425
• Device Lot Number: L45331
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2019
• 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): Hospitalization; Required Intervention