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

Model Number 18320

Device Problems Loss of or Failure to Bond (1068); Unintended Movement (3026)

Patient Problems Fatigue (1849); Hyperglycemia (1905); Abdominal Cramps (2543)

Event Date 03/07/2023

Event Type  malfunction  

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.It was reported that the cannula had dislodged from the infusion site.This condition could interrupt insulin delivery and contribute to 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 communicating with the pdm, deployment, delivering fluid, occlusion detection, and freedom from hazard alarms.

Event Description

It was reported the patient's blood glucose level (bg) read "high" (>27.8 mmol/l,>500 mg/dl) with ketones of 4.6 mmol/l while wearing the pod between 24 and 36 hours.Symptoms reported include fatigue, abdominal pain and confusion.The pod reportedly fell off the infusion site (leg), causing the cannula to dislodge.As treatment, a new pod was applied and the patient drank lots of fluids.

• Brand Name: OMNIPOD DASH 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: 16500975
• MDR Text Key: 310854623
• Report Number: 3004464228-2023-06396
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 20385082000020
• UDI-Public: (01)20385082000020(11)211220(17)230620(10)PD1K12202131
• 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: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/20/2023
• Device Model Number: 18320
• Device Catalogue Number: BLE-I1-529
• Device Lot Number: PD1K12202131
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 6 YR
• Patient Sex: Female