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

Model Number 19191

Device Problem Material Twisted/Bent (2981)

Patient Problem Hyperglycemia (1905)

Event Date 08/18/2020

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 exceeded 300 mg/dl while wearing the pod for more than 48 hours.When removed from the infusion site (hip/buttocks), the pod's cannula was found kinked/bent.As treatment for hyperglycemia, a new pod was applied.

Manufacturer Narrative

The received device had the cannula assembly fully deployed.Inspection of the cannula assembly found no problems with fluid passing freely through the complete fluid path, though the exposed portion of the soft cannula was kinked.It could not be determined when this damage occurred.The data showed no timeouts, drive stalls, or pulse width increases that would indicate the pod struggling to deliver insulin while worn.

• Brand Name: OMNIPOD INSULIN MANAGEMENT SYSTEM
• Type of Device: PUMP, INFUSION, INSULIN
• Manufacturer (Section D): INSULET CORPORATION; 100 nagog park; acton MA 01720
• MDR Report Key: 10475028
• MDR Text Key: 205105196
• Report Number: 3004464228-2020-13836
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 20385081120033
• UDI-Public: (01)20385081120033(11)200522(17)211122(10)L71041
• 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: 08/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/22/2021
• Device Model Number: 19191
• Device Catalogue Number: ZXP425
• Device Lot Number: L71041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2020
• Date Manufacturer Received: 09/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 7 YR