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

Model Number 14500-5A

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Hypoglycemia (1912)

Event Date 04/10/2022

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 er visit 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 by mother that the patient had been taken to the emergency room (er) due to hypoglycemia.The patient's blood glucose (bg) levels dropped to 40 mg/dl; mother reported the personal diabetes manager (pdm) was giving incorrect bg readings.Symptoms reported include patient being unable to move legs/arms and feeling cold.Patient was given a granola bar and juice and remained in the er at the time of reporting.Good faith attempts for additional medical event details were not successful.The patient's blood glucose history is as follows: (b)(6).

• 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: 14117657
• MDR Text Key: 289324595
• Report Number: 3004464228-2022-06199
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 10385081140003
• UDI-Public: (01)10385081140003(11)200822(10)L61274
• 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: 04/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 14500-5A
• Device Catalogue Number: UST400
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2020
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 17 YR
• Patient Sex: Female