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

Model Number 18325

Device Problem Material Twisted/Bent (2981)

Patient Problem Hyperglycemia (1905)

Event Date 04/27/2023

Event Type  malfunction  

Event Description

It was reported that a patient's blood glucose levels (bg) reached over 500 mg/dl, while wearing the pod between 1 and 4 hours.The patient reported cannula being bent when it was removed from the infusion site.For treatment, the patient changed out the pod for a new pod.

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.

Manufacturer Narrative

The received device had the cannula assembly fully deployed.Inspection of the soft cannula did not find it bent, kinked, or damaged.The download data from the pod contained no timeouts, drive stalls, or hazard alarms, indicating that there was no struggle to deliver insulin.The investigation found no evidence of any damage or manufacturing deficiencies that would result in fluid failing to flow through the complete fluid path.

• 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: thom mcnamara ; 100 nagog park; acton, MA 01720 ; 9786007000
• MDR Report Key: 16831660
• MDR Text Key: 314172500
• Report Number: 3004464228-2023-10963
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 20385082000051
• UDI-Public: (01)20385082000051(11)220617(17)231217(10)PD1U06172231
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K211575
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/17/2023
• Device Model Number: 18325
• Device Catalogue Number: BLE-P1-525
• Device Lot Number: PD1U06172231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Male