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

Model Number	18900-5A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Diarrhea (1811); Vomiting (2144); Elevated ketones/Diabetic Ketoacidosis (2364)
Date of Event	06/26/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had been hospitalized with diabetic ketoacidosis (dka).Symptoms reported include diarrhea, vomiting and difficulty breathing.The patient reports they were unable to apply a pod due to receiving a hazard alarm on their personal diabetes manager (pdm).Once at the hospital the patients was diagnosed with diabetic ketoacidosis (dka) as well as low phosphorus and magnesium.The patient was transferred to the intensive care unit (icu).The patient was treated with both insulin and keppra.The patient was prescribed insulin pens.The patient was released from the hospital after 3 days.The patient was assisted by insulet with resetting their pdm and activating a new pod after this event.
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 diabetic ketoacidosis.No lot release records were reviewed, as the product lot number was not provided."high blood glucose is a common symptom for people with diabetes (glucose monitoring data from people with diabetes indicate that on average, they can experience blood glucose levels above 250 mg/dl for 14-25% of the time[1][2][3].), and it would be challenging to speculate on a cause for the complaints without receiving the devices back for an engineering investigation.[1] beck rw, bergenstal rm, cheng p, kollman c, carlson al, johnson ml, rodbard d.The relationships between time in range, hyperglycemia metrics, and hba1c.J diabetes sci technol 2019;13:614-626 [1] welsh jb, derdzinski m, parker as, puhr s, jimenez a, walker t.Real-time sharing and following of continuous glucose monitoring data in youth.Diabetes ther 2019;10:751-755 [1] puhr s, derdzinski m, welsh jb, parker as, walker t, price da.Real-world hypoglycemia avoidance with a continuous glucose monitoring system's predictive low glucose alert.Diabetes technol ther 2019;21:155-158".

• Brand Name: OMNIPOD INSULIN MANAGEMENT SYSTEM
• 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: 17322477
• Report Number: 3004464228-2023-17917
• Device Sequence Number: 6319155
• Product Code: LZG
• UDI-Device Identifier: 10385081120012
• UDI-Public: (01)10385081120012(11)191101(10)L61195
• 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): 06/26/2023

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: L61195
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/26/2023
• Initial Report FDA Received Date: 07/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2019
• 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: 28 YR
• Patient Sex: Female