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

Model Number 18320

Device Problem Insufficient Information (3190)

Patient Problems Chest Pain (1776); Hyperglycemia (1905); Pneumonia (2011); Virus (2136); Vomiting (2144); Heart Failure (2206)

Event Date 03/13/2020

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 [er visit/hospitalization] and hyperglycemia.No lot release records were reviewed and the product lot met all acceptance criteria.Omnipod dash insulin management system ¿ user guide.Model: 18320.18296-eng-aw rev b 06/18.Blood glucose readings.Chapter 4 / page 56.Warnings: blood glucose readings below 70 mg/dl may indicate hypoglycemia (low blood glucose).Blood glucose readings above 250 mg/dl may indicate hyperglycemia (high blood glucose).Follow your healthcare provider's suggestions for treatment.Living with diabetes.Chapter 13 / page 176.Hyperglycemia 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 blood glucose level to confirm.

Event Description

It was reported that the patient's blood glucose (bg) values reached 600 mg/dl.The patient was suffering from severe chest pain, vomiting and pneumonia.The patient was taken to the emergency room, where they were screened and quarantined for coronavirus.The patient also had a heart attack.For treatment, the patient was given insulin, blood thinners and baby aspirin.The ketones were checked, but the results were unknown.The patient was in the hospital from (b)(6) of 2020.

• Brand Name: OMNIPOD DASH¿ 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: 9987942
• MDR Text Key: 189912283
• Report Number: 3004464228-2020-05831
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 20385082000020
• UDI-Public: (01)20385082000020
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 18320
• Device Catalogue Number: BLE-I1-529
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/08/2020
• 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; Required Intervention
• Patient Age: 56 YR