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

Model Number 18320

Device Problems Failure to Fire (2610); Activation Problem (4042)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/10/2023

Event Type  malfunction  

Event Description

It was reported that the needle and cannula did not deploy, indicating a failure of the needle mechanism.The pod was not worn, and the blood glucose (bg) levels were unaffected.

• 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: michael spears ; 100 nagog park; acton, MA 01720 ; 9786007000
• MDR Report Key: 16369355
• MDR Text Key: 309466335
• Report Number: 3004464228-2023-04476
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 20385082000020
• UDI-Public: (01)20385082000020(11)211212(17)230612(10)PD1K12122131
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192659
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/10/2023

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: 06/12/2023
• Device Model Number: 18320
• Device Catalogue Number: BLE-I1-529
• Device Lot Number: PD1K12122131
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/10/2023
• Initial Date FDA Received: 02/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2021
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Sex: Male