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

Model Number 18320

Device Problems Retraction Problem (1536); Failure to Fire (2610)

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

Event Date 04/20/2023

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 the needle did not retract; indicating the needle mechanism did not function as intended.No adverse patient impact was reported.

Manufacturer Narrative

B5 - describe event or problem.From: it was reported the needle did not retract; indicating the needle mechanism did not function as intended.No adverse patient impact was reported.To: it was reported the needle did not deploy.The pod was worn on the patient's abdomen.No adverse patient impact was reported.H6 - adverse event problem.Medical device problem code from: a0510 retraction problem.To: a050501 failure to fire.

Event Description

It was reported the needle did not deploy.The pod was worn on the patient's abdomen.No adverse patient impact was reported.

Manufacturer Narrative

The device was received in the not deployed position.The download data indicates that the first priming sequence ended prematurely due to a rotational sensor malfunction, resulting in completion of the second priming sequence without the needle deploying.The commutator cap was inspected but not abnormities were noted.The cause of the rotational sensor issue could not be determined.However it could be determined that the observed rotational senor issue prevented deployment of the device.

• 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: 16796490
• MDR Text Key: 313836256
• Report Number: 3004464228-2023-10378
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 20385082000020
• UDI-Public: (01)20385082000020(11)211014(17)230414(10)PD1K10142121
• 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: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/14/2023
• Device Model Number: 18320
• Device Catalogue Number: BLE-I1-529
• Device Lot Number: PD1K10142121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male