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

Model Number	18900-5A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	09/04/2023
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 hospitalization 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 went to the er (emergency room) with hyperglycemia.The patient was still in the er at the time of reporting.The patient's blood glucose levels reached >250 mg/dl while wearing the pod for an unknown amount of time.It was reported by the patient that the pdm (personal diabetes manager) was glitching, vibrating, beeping and was not able to deliver a bolus.Symptoms reported include coughing and feeling overall ill.No treatment was stated since the patient was still in the er.The pod was worn when seeking medical attention.Additional information was solicited but unavailable.
Additional Manufacturer Narrative
It was reported that the patient went to the er (emergency room) with hyperglycemia.The patient was still in the er at the time of reporting.The patient's blood glucose levels reached >250 mg/dl while wearing the pod for an unknown amount of time.It was reported by the patient that the pdm (personal diabetes manager) was glitching, turning off, vibrating, beeping and was not able to deliver a bolus.Symptoms reported include coughing and feeling overall ill.The patient was treated with iv(intravenous) fluids and an insulin shot.The pod was worn when seeking medical attention.
Event or Problem Description
It was reported that the patient went to the er (emergency room) with hyperglycemia.The patient was still in the er at the time of reporting.The patient's blood glucose levels reached >250 mg/dl while wearing the pod for an unknown amount of time.It was reported by the patient that the pdm (personal diabetes manager) was glitching, turning off, vibrating, beeping and was not able to deliver a bolus.Symptoms reported include coughing and feeling overall ill.The patient was treated with iv(intravenous) fluids and an insulin shot.The pod was worn when seeking medical attention.

• 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: 17861398
• Report Number: 3004464228-2023-27201
• Device Sequence Number: 20315751
• Product Code: LZG
• UDI-Device Identifier: 10385081120012
• UDI-Public: (01)10385081120012(11)210706(10)L61347
• 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): 09/04/2023

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: 18900-5A
• Device Catalogue Number: PDM-UST400
• Device Lot Number: L61347
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/04/2023
• Supplement Date Received by Manufacturer: 09/04/2023
• Initial Report FDA Received Date: 10/03/2023
• Supplement Report FDA Received Date: 10/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2021
• 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: 15 YR
• Patient Sex: Male