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

Model Number 18320

Device Problems Fluid/Blood Leak (1250); Material Twisted/Bent (2981)

Patient Problems Hyperglycemia (1905); Malaise (2359)

Event Date 09/09/2021

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 the patient's blood glucose level rose to above 600 mg/dl while wearing the pod longer than 48 hours.The pod leaking insulin during wear was also reported.When removed from the infusion site (abdomen), the pod's cannula was found bent.Ketones were checked and found to be high.As treatment, the patient administered correction boluses and drank a lot of water.The patient's blood glucose and insulin history are as follows: time bg(mg/dl) bolus(u) 10:00pm 200 3.0, 8:00am 600 n/a.

Manufacturer Narrative

The soft cannula was not observed to be bent/kinked.The download data did not show any timeouts or drive stalls during the run that would indicate a failure of the pod to deliver insulin.The exposed portion of the soft cannula was found to have a tear.Fluid was seen leaking from this tear.Although the cannula was damaged, the timing and cause of the damage is unknown.

• 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: 12510913
• MDR Text Key: 272645539
• Report Number: 3004464228-2021-16758
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 20385082000020
• UDI-Public: (01)20385082000020(11)210311(17)220911(10)PD1K03112121
• 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: 09/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/11/2022
• Device Model Number: 18320
• Device Catalogue Number: BLE-I1-529
• Device Lot Number: PD1K03112121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2021
• Date Manufacturer Received: 10/13/2021
• Patient Sequence Number: 1
• Patient Age: 62 YR