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

Model Number 19191

Device Problem Insufficient Information (3190)

Patient Problems Hyperglycemia (1905); Nausea (1970); Diabetic Ketoacidosis (2364); No Code Available (3191)

Event Date 09/03/2020

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 hospitalization and diabetic ketoacidosis.Lot release records were reviewed and the product lot met all acceptance criteria.

Event Description

It was reported that a patient went to the hospital and was diagnosed with diabetic ketoacidosis (dka).The patient's blood glucose values reached 300 mg/dl.For treatment, the patient states she got an (iv) intravenous for insulin and fluids and she received morphine for pain.The patient also received a prescription called levofloxacin 500 mg, once per day for 9 days and a probiotic 5mg at once per day.The patient was nauseous and the ketones were positive.The patient wore the pod between 4 and 24 hours on the abdomen.The patient had kidney stones.

Manufacturer Narrative

The download data showed an 0x1c alarm generated, indicating that pod had reached expiration time (ran for 80 hours).Generation of the hazard alarm stopped the delivery of insulin.The pod ran for 1861 pulses before getting deactivated.

• Brand Name: OMNIPOD INSULIN MANAGEMENT SYSTEM
• Type of Device: PUMP, INFUSION, INSULIN
• Manufacturer (Section D): INSULET CORPORATION; 100 nagog park; acton MA 01720
• MDR Report Key: 10581229
• MDR Text Key: 208407411
• Report Number: 3004464228-2020-15242
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 20385081120033
• UDI-Public: (01)20385081120033(11)191007(17)210407(10)L45176
• Combination Product (y/n): N
• PMA/PMN Number: K192659
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 09/13/2020

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: 04/07/2021
• Device Model Number: 19191
• Device Catalogue Number: ZXP425
• Device Lot Number: L45176
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2020
• Initial Date Manufacturer Received: 09/13/2020
• Initial Date FDA Received: 09/24/2020
• Supplement Dates Manufacturer Received: 10/21/2020
• Supplement Dates FDA Received: 11/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR