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

Model Number 19191

Device Problem Material Twisted/Bent (2981)

Patient Problems Diarrhea (1811); Hyperglycemia (1905); Nausea (1970); Diabetic Ketoacidosis (2364)

Event Date 05/21/2023

Event Type  Injury  

Manufacturer Narrative

According to the complainant the device will not be returned for investigation.We are unable to confirm the bent cannula or to determine if it could have contributed to the reported hyperglycemia and hospitalization.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.

Event Description

It was reported that the patient had been hospitalized with diabetic ketoacidosis (dka).The patient's blood glucose levels reached 412 mg/dl while wearing the pod longer than 48 hours.When removed from the infusion site (hip/buttocks), the pod's cannula was found bent.Symptoms reported include nausea and loose stool.The patient was placed on an intravenous therapy of fluids including potassium, meclizine and given (10u) of insulin.The patient was still hospitalized at the time of the call.

• 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: thom mcnamara ; 100 nagog park; acton, MA 01720 ; 9786007000
• MDR Report Key: 17035550
• MDR Text Key: 316291111
• Report Number: 3004464228-2023-13777
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 20385081120033
• UDI-Public: (01)20385081120033(11)220103(17)230703(10)L72373
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K211575
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/22/2023

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/03/2023
• Device Model Number: 19191
• Device Catalogue Number: ZXP425
• Device Lot Number: L72373
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/22/2023
• Initial Date FDA Received: 05/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 67 YR
• Patient Sex: Female