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

Model Number 19191

Device Problem Material Twisted/Bent (2981)

Patient Problems Hyperglycemia (1905); Nausea (1970); Vomiting (2144); No Code Available (3191)

Event Date 10/20/2020

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, bent/kinked cannula 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 388 mg/dl.For treatment, the patient stated that she was given phenergan for nausea, three (3) bags of intravenous (iv) saline, iv insulin, two (2) bags of iv calcium and a heparin shot, while in the hospital's intensive care unit.The patient had flu like symptoms, body aches and was vomiting.The ketones were very high.The patient wore the pod between 4 and 24 hours on the hips/buttocks.The cannula was bent/kinked.The patient was discharged on (b)(6)2020 after 1 day.

Manufacturer Narrative

The exposed portion of the soft cannula was observed to bent.During the investigation, the bend did not prevent fluid from exiting the distal tip of the soft cannula and no signs of leakage were observed.The data downloaded from the device did not show any signs of struggle during the run.No other damages or defects were found with the device.Although the cannula was damaged, the timing and cause of the damage is unknown.No blood was observed on or within the device.The cannula assembly and bottom housing were inspected for manufacturing deficiencies that could cause bleeding or bruising and no issues were found.

• 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: 10802248
• MDR Text Key: 215082993
• Report Number: 3004464228-2020-17362
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 20385081120033
• UDI-Public: (01)20385081120033(11)200530(17)211130(10)L45825
• 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: 10/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2021
• Device Model Number: 19191
• Device Catalogue Number: ZXP425
• Device Lot Number: L45825
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2020
• Date Manufacturer Received: 12/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR