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

Model Number 18320

Device Problems Difficult to Insert (1316); Material Twisted/Bent (2981)

Patient Problems Extreme Exhaustion (1843); Hyperglycemia (1905)

Event Date 12/23/2020

Event Type  Injury  

Manufacturer Narrative

According to the complainant the device will not be returned for investigation.We are unable to determine if any product condition could have contributed to the reported hospitalization and diabetic ketoacidosis.In addition it was reported the cannula was possibly not inserted correctly into the infusion site and we are unable to confirm the bent cannula or to determine if it could have contributed to the reported hyperglycemia.No lot release records were reviewed, as the product lot number was not provided.

Event Description

It was reported that the patient had been hospitalized with diabetic ketoacidosis (dka) while wearing a pod between 4 and 24 hours.It was reported while the patient was at a routine visit with their health care provider the patient had experienced symptoms of not being able to stay awake as well as hyperglycemia.The patient's blood glucose level read high (>500 mg/dl).The patient was sent to the emergency room in the same building as the patients health care provider.Once in the emergency room the patient was treated with intravenous fluids and insulin.In addition it was reported once the pod was removed from the infusion site (abdomen) the patient was unsure if the cannula was properly seated in the infusion site (abdomen) and was bent.

• 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: 11089297
• MDR Text Key: 224124556
• Report Number: 3004464228-2020-20218
• 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: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 18320
• Device Catalogue Number: BLE-I1-529
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 6 YR