MAUDE Adverse Event Report: INSULET CORPORATION OMNIPOD GO INSULIN DELIVERY DEVICE; INSULIN PUMP

Model Number	PT-000435
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the complainant the device will not be returned for investigation.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 communicating with the pdm, deployment, delivering fluid, occlusion detection, and freedom from hazard alarms.
Event or Problem Description
It was reported by the patient that the pod's cannula did not deploy indicating a needle mechanism failure.
Additional Manufacturer Narrative
The device was received not deployed.Rotational sensor errors were seen in the download data causing first prime to end earlier than expected and the firing flat not being properly lined up by the end of second prime.Rotational sensor errors were replicated in the rerun data.Contamination was observed on the commutator cap, which can be confirmed as the cause of the rotational sensor errors and device not deploying.

• Brand Name: OMNIPOD GO INSULIN DELIVERY DEVICE
• Common Device Name: INSULIN PUMP
• 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: 19181550
• Report Number: 3004464228-2024-14853
• Device Sequence Number: 15273946
• Product Code: LZG
• UDI-Device Identifier: 10385084000106
• UDI-Public: (01)10385084000106(11)230715(17)250115(10)PH1K07152311
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K203768
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2024

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/15/2025
• Device Model Number: PT-000435
• Device Catalogue Number: POD-BLE-H1-520
• Device Lot Number: PH1K07152311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/14/2024
• Supplement Date Received by Manufacturer: 05/13/2024
• Initial Report FDA Received Date: 04/25/2024
• Supplement Report FDA Received Date: 05/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 12 YR
• Patient Sex: Male