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

Model Number 18320

Device Problem Material Twisted/Bent (2981)

Patient Problems Hyperglycemia (1905); Irritation (1941)

Event Date 11/24/2020

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned/received to date.If the device is received, a supplemental report will be submitted with the investigation results.We are unable to confirm the bent cannula or to determine if it could have contributed to the reported hyperglycemia.Lot release records were reviewed and the product lot met all acceptance criteria.Specifically, a pod is paired to a pdm and put through simulated use testing including confirming the blue soft cannula is inspected for any damage.

Event Description

It was reported that the patient's blood glucose levels reached near 500 mg/dl while wearing the pod between 4 and 24 hours.When removed from the infusion site (leg), the pod's cannula was found kinked/bent.As treatment for hyperglycemia, insulin was delivered and a water was consumed.

Manufacturer Narrative

The received device had the cannula assembly deployed.The exposed portion of the soft cannula was found bent/kinked, although it cannot be determined when or how this damage occurred.Fluid was able to flow through the fluid path with no signs of struggle.Blood was observed on the adhesive pad, however, no evidence was found that would result in bleeding or skin irritation to occur at the infusion site; a root cause could not be determined.No leaks were found during testing, and no other defects or deficiencies were found that would result in a failure of the device to deliver insulin.

• Brand Name: OMNIPOD DASH INSULIN MANAGEMENT SYSTEM
• Type of Device: PUMP, INFUSION, INSULIN
• Manufacturer (Section D): INSULET CORPORATION; 100 nagog park; acton MA 01720
• MDR Report Key: 10960270
• MDR Text Key: 219978495
• Report Number: 3004464228-2020-18982
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 20385082000020
• UDI-Public: (01)20385082000020(11)190321(17)210430(10)PD1C10301951
• Combination Product (y/n): N
• PMA/PMN Number: K192659
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2021
• Device Model Number: 18320
• Device Catalogue Number: BLE-I1-529
• Device Lot Number: PD1C10301951
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2021
• Date Manufacturer Received: 02/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 37 YR