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

Model Number	14500-5A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	05/29/2024
Type of Reportable Event	Serious Injury
Additional 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 emergency room 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 or Problem Description
It was reported that the patient visited the er (emergency room) with hyperglycemia.The patient's guardian reported that the pdm (personal diabetes manager) presented with a hazard alarm, that they were unable to reset in order to deliver insulin via the pod.The guardian reported the patient did not have an alternative form of insulin delivery.No further information is available.Three due diligence attempts were made to obtain further information without success.
Additional Manufacturer Narrative
Additional information received: blood glucose levels were >400 mg/dl.Patient was treated with iv insulin and given prescription for insulin pens to use until patient received new controller.Patient was released within 9 hours.
Event or Problem Description
It was reported that the patient visited the er (emergency room) with hyperglycemia.The patient's guardian reported that the pdm (personal diabetes manager) presented with a hazard alarm, that they were unable to reset in order to deliver insulin via the pod.The guardian reported the patient did not have an alternative form of insulin delivery.No further information is available.Three due diligence attempts were made to obtain further information without success.

• Brand Name: OMNIPOD INSULIN PUMP
• Common Device Name: 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: thom mcnamara ; 100 nagog park; acton, MA 01720 ; 9786007000
• MDR Report Key: 19499040
• Report Number: 3004464228-2024-21360
• Device Sequence Number: 7926072
• Product Code: LZG
• UDI-Device Identifier: 10385081140003
• UDI-Public: (01)10385081140003(11)210312(10)L61324
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K211575
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 14500-5A
• Device Catalogue Number: UST400
• Device Lot Number: L61324
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/29/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/10/2024
• Supplement Report FDA Received Date: 07/08/2024
• Date Device Manufactured: 03/12/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 12 YR
• Patient Sex: Male