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	03/09/2024
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 confirm the reported the reported thermal event.No lot release records were reviewed, as the product lot number was not provided.
Event or Problem Description
It was reported that the patient had been hospitalized with hyperglycemia.The patient's blood glucose levels reached 371 mg/dl while wearing the pod.The patient reports their personal diabetes manager (pdm) would not turn on after changing the batteries and attempting a reset.The patient reports receiving a hazard alarm to remove the pod prior to their pdm not turning on.The patient applied a new pod prior to going to the hospital.Once at the hospital the patient was treated with intravenous fluids as well as insulin.The patient remains in the hospital at the time of this call.

• 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: 18877571
• Report Number: 3004464228-2024-08831
• Device Sequence Number: 20793165
• Product Code: LZG
• UDI-Device Identifier: 10385081140003
• UDI-Public: (01)10385081140003
• 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
• Report Date (Section B): 03/11/2024

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/09/2024
• Initial Report FDA Received Date: 03/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 21 YR
• Patient Sex: Male