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

Model Number 18900-5F

Device Problem Failure to Reset (1532)

Patient Problem Diabetic Ketoacidosis (2364)

Event Date 08/01/2022

Event Type  Injury  

Event Description

It was reported the personal diabetes manager (pdm) continued to alarm and was unable to reset.The patient removed and deactivated the pod.The healthcare provider (hcp) diagnosed the patient with diabetic ketoacidosis.The patient received insulin pens as a back up method from the hcp for treatment.

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 diabetic ketoacidosis.No lot release records were reviewed, as the product lot number was not provided.

• 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: 15163320
• MDR Text Key: 297226027
• Report Number: 3004464228-2022-13677
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 10385081120098
• UDI-Public: (01)10385081120098
• 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: 08/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 18900-5F
• Device Catalogue Number: DET450
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 10 YR
• Patient Sex: Male