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

Model Number 19191

Device Problem Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Fatigue (1849); Hyperglycemia (1905)

Event Date 10/14/2020

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 er visit and 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 that the patient visited the emergency room (er) due to high blood glucose (bg) levels of 309 mg/dl, fatigue and abdominal pain, while wearing the pod between 4 and 24 hours on the abdomen.Multiple corrections were administered using the pod at home (total of 32.2 units) but the bg levels did not decrease.At the hospital, the patient was treated with insulin and fluids (method unknown).

Manufacturer Narrative

The received device had the cannula assembly deployed.A tear was observed in the unexposed section of the soft cannula, allowing for fluid to exit through the tear.It cannot be determined when or how this damage occurred.Corrosion was present on the pcb assembly and the batteries, although data was able to be downloaded from the pcb using a 3 v external power source.The pod registered an 0x33 hazard alarm and the kill switch was activated.The pod was connected to the master pdm using a 4.5 v external power source with no issues and a 5 unit test bolus was run, which produced a drive stall and time out as corrosion prevented the drive mechanism from rotating.

• 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: 10739948
• MDR Text Key: 213186244
• Report Number: 3004464228-2020-16784
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 20385081120033
• UDI-Public: (01)20385081120033(11)191217(17)210617(10)L45358
• 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: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/17/2021
• Device Model Number: 19191
• Device Catalogue Number: ZXP425
• Device Lot Number: L45358
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• Date Manufacturer Received: 11/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 13 YR