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

Model Number PT-000011

Device Problems Failure to Power Up (1476); Data Back-Up Problem (2902); Data Problem (3196)

Patient Problem Hyperglycemia (1905)

Event Date 09/23/2022

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.We are unable to confirm the power and data issue or to determine if it could have contributed to the reported 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 confirming the blue soft cannula is inspected for any damage.

Event Description

It was reported the personal diabetes manger (pdm) data upload and export function was no longer working properly.The pdm was providing incorrect calculations and reverted the display settings to mg/dl as opposed to the programmed mmol/l set up by user.The pdm was power cycled by the user and failed to turn on.The patient's blood glucose levels reached greater than 13.9 mmol/l (250 mg/dl).

• 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: 15538117
• MDR Text Key: 301118256
• Report Number: 3004464228-2022-18505
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 10385082000146
• UDI-Public: (01)10385082000146(11)200812(10)L000270
• 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: 09/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: PT-000011
• Device Catalogue Number: INT2-D001-MM
• Device Lot Number: L000270
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2020
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Female