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

Model Number 14500-5A

Device Problem Improper Flow or Infusion (2954)

Patient Problem Hypoglycemia (1912)

Event Date 08/23/2022

Event Type  malfunction  

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's blood glucose (bg) values dropped below 70 mg/dl.The patient stated that the pdm delivered 8 boluses on its own.No further details to report.

Manufacturer Narrative

Correction to d(4): model no changed from 18900-5a to 14500-5a.Catalog no changed from unavailable to ust400.Unique identifier (udi) # changed to (b)(4).Correction to g(5): pma/510(k) # changed from unavailable to k192659.

• Brand Name: OMNIPOD INSULIN PUMP
• 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: 15388323
• MDR Text Key: 305415531
• Report Number: 3004464228-2022-16402
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 10385081140003
• UDI-Public: (01)10385081140003(11)211018(10)L61363
• 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,Followup
• Report Date: 08/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 14500-5A
• Device Catalogue Number: UST400
• Device Lot Number: L61363
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2021
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 10 YR
• Patient Sex: Female