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

Model Number 18320

Device Problem Positioning Failure (1158)

Patient Problem No Information (3190)

Event Date 12/05/2020

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 reported needle mechanism failure or to determine its root cause.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 that the device deployed the cannula correctly.

Event Description

It was reported by the patient that the needle mechanism did not deploy as intended during activation.

Manufacturer Narrative

The device was received with the cannula not deployed.During the investigation, the ratchet gear was manually advanced and the cannula assembly successfully deployed.The download data indicates that the device ran 45 pulses and then was deactivated before running the second priming sequence.No issues were seen with the device.Based on the investigation the device functioned as intended and was deactivated before running enough pulses to deploy.

• 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: 10993192
• MDR Text Key: 220970838
• Report Number: 3004464228-2020-19552
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 20385082000020
• UDI-Public: (01)20385082000020(11)190901(17)210301(10)PD1C09011951
• 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: 12/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/01/2021
• Device Model Number: 18320
• Device Catalogue Number: BLE-I1-529
• Device Lot Number: PD1C09011951
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2021
• Initial Date Manufacturer Received: 12/07/2020
• Initial Date FDA Received: 12/11/2020
• Supplement Dates Manufacturer Received: 01/26/2021
• Supplement Dates FDA Received: 02/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 41 YR