MAUDE Adverse Event Report: INSULET CORPORATION OMNIPOD DASH, PODS 10-PACK; PUMP, INFUSION, INSULIN

Model Number PT-000029

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hyperglycemia (1905); Nausea (1970); Numbness (2415)

Event Date 10/03/2021

Event Type  Injury  

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 determine if any product condition could have contributed to the reported er visit and 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 communicating with the pdm, deployment, delivering fluid, occlusion detection, and freedom from hazard alarms.

Event Description

It was reported that the patient visited the emergency room (er) due to high blood glucose (bg) levels of 27 mmol/l (486 mg/dl) nausea and numbness on the face, while wearing the pod on the arm between 24 and 36 hours.At the hospital, the patient was placed on an intravenous (iv) drip of saline and given insulin manually through injections with some extra ones to take home.

Manufacturer Narrative

The device was received and evaluated.The device data shows that the pod delivered 1067 pulses, however the spring latch was found to be restraining the clutch spring tine in the stored energy state.This indicates that the spring latch was misaligned.Consequently, when the ratchet gear was manually advanced the plunger did not descend in the reservoir and fluid did not pass through the fluid path.The misaligned spring latch prevented the customer from receiving their intended insulin dose.

• Brand Name: OMNIPOD DASH, PODS 10-PACK
• 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: 12591384
• MDR Text Key: 275208555
• Report Number: 3004464228-2021-17735
• Device Sequence Number: 1
• Product Code: LZG
• 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,Followup
• Report Date: 10/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/17/2022
• Device Model Number: PT-000029
• Device Catalogue Number: POD-BLE-C1-529
• Device Lot Number: PD1C12172051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/03/2021
• Initial Date FDA Received: 10/07/2021
• Supplement Dates Manufacturer Received: 11/18/2021
• Supplement Dates FDA Received: 11/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2020
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 28 YR
• Patient Sex: Male