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

Model Number 18025

Device Problem Material Twisted/Bent (2981)

Patient Problems Hyperglycemia (1905); Nausea (1970); Chills (2191)

Event Date 07/26/2022

Event Type  Injury  

Event Description

It was reported that the patient had been to the emergency room with hyperglycemia.The patient's blood glucose levels reached 571 mg/dl while wearing the pod between 4 and 24 hours.Symptoms reported include nausea, short of breathe, body aches, feeling very cold and dry heaves.The patient was diagnosed with acute hyperglycemia.The patient was treated with iv (intravenous) drip of fluids and injected her with lispro.The patient was released the same day.The pod was still being worn in the emergency room.It was also discovered that the cannula was bent.

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 hospitalization and hyperglycemia.We are unable to confirm the bent cannula or to determine if it could have contributed to the reported 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 confirming the blue soft cannula is inspected for any damage, communicating with the pdm, deployment, delivering fluid, occlusion detection, and freedom from hazard alarms.

Manufacturer Narrative

Correction to d(4): catalog no changed from unavailable to zxp425.Correction to g(5): pma/510(k) # changed from unavailable to k192659.

• Brand Name: OMNIPOD 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: 15156100
• MDR Text Key: 297141685
• Report Number: 3004464228-2022-13574
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 20385081120057
• UDI-Public: (01)20385081120057(11)211202(17)230602(10)L72353
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/02/2023
• Device Model Number: 18025
• Device Catalogue Number: ZXP425
• Device Lot Number: L72353
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 70 YR
• Patient Sex: Female