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

Model Number 18325

Device Problem Insufficient Information (3190)

Patient Problems Hypoglycemia (1912); Loss of consciousness (2418); Convulsion/Seizure (4406)

Event Date 02/22/2023

Event Type  Injury  

Manufacturer Narrative

According to the complainant the device will not be returned for investigation.We are unable to determine if any product condition could have contributed to the reported hospitalization and hypoglycemia.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 went to the hospital and was diagnosed with blood glucose (bg) values that dropped to 27 mg/dl.The patient was having seizures, lethargic and was losing consciousness.For treatment, the patient was given dextrose.The pod was worn between 4 and 24 hours on the leg.The patient is currently admitted.

• 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: 16435862
• MDR Text Key: 310149101
• Report Number: 3004464228-2023-05322
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 20385082000051
• UDI-Public: (01)20385082000051(11)211016(17)230416(10)PD1U10162121
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/16/2023
• Device Model Number: 18325
• Device Catalogue Number: BLE-P1-525
• Device Lot Number: PD1U10162121
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 23 MO
• Patient Sex: Male