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

Model Number 14000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Hyperglycemia (1905); Nausea (1970); Pain (1994); Vomiting (2144); Diabetic Ketoacidosis (2364)

Event Date 01/01/2022

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 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.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.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.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.

Event Description

It was reported that the patient was taken to the hospital by ambulance and was diagnosed with diabetic ketoacidosis (dka).The patient's blood glucose (bg) values reached 346 mg/dl.The patient had nausea, hot flashes and vomiting.The patient was in pain from a back injury sustained from falling.For treatment, the patient was given insulin.The pod was worn between 4 and 24 hours on the leg.The patient was discharged after 1.5 days.The pod was discarded.

• 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: 13836057
• MDR Text Key: 287582149
• Report Number: 3004464228-2022-04595
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 20385081120002
• UDI-Public: (01)20385081120002
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122953
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 14000
• Device Catalogue Number: ZXP425
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female