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

Model Number 18320

Device Problem Insufficient Information (3190)

Patient Problems Fainting (1847); Hyperglycemia (1905); Loss of consciousness (2418)

Event Date 03/19/2020

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 hypoglycemia.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.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 blood glucose level to confirm.

Event Description

It was reported that the patient had been hospitalized with hypoglycemia.The patient's blood glucose levels had gone down to 48 mg/dl while wearing the pod for longer than 48 hours on the back.Symptoms reported include the patient passing out.The patient was treated by the paramedics with an intravenous of insulin and was given a tube of icing to consume.The patient received 3 stitches in his head due to the fall from passing out in addition he was given a cat scan and neck x-rays.At the hospital the patient's pod was suspended but once the patient¿s glucose level returned to normal range the pod use was resumed.The patient's blood glucose and insulin history are as follows: (b)(6).

• 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: 9928691
• MDR Text Key: 187056096
• Report Number: 3004464228-2020-05061
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 20385082000020
• UDI-Public: (01)20385082000020(11)190707(17)210107(10)PD1C07071951
• 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: 03/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/07/2021
• Device Model Number: 18320
• Device Catalogue Number: BLE-I1-529
• Device Lot Number: PD1C07071951
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2019
• 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
• Patient Age: 77 YR