MAUDE Adverse Event Report: NOVO NORDISK A/S NOVOPEN 5; INSULIN DELIVERY DEVICE

Model Number N/A

Device Problems Display Difficult to Read (1181); Improper or Incorrect Procedure or Method (2017)

Patient Problem Diabetic Ketoacidosis (2364)

Event Date 10/13/2023

Event Type  Injury  

Event Description

[preferred term] (related symptoms if any separated by commas).Ketoacidosis (type 1 diabetes mellitus) [diabetic ketoacidosis].Memory screen of novopen 5 displayed messy words [device information output issue].Pen was stored with the needle on it [product storage error].Case description: this serious spontaneous case from china was reported by a consumer as "ketoacidosis (type 1 diabetes mellitus) (diabetic ketoacidosis)" beginning on (b)(6) 2023, "memory screen of novopen 5 displayed messy words (device image display issue)" with an unspecified onset date, "pen was stored with the needle on it (device stored with needle attached)" with an unspecified onset date, and concerned a 22 years old female patient who was treated with novopen 5 (insulin delivery device) from unknown start date for "device therapy", novopen 5 (insulin delivery device) from unknown start date for "device therapy", novorapid penfill (insulin aspart) solution for injection, 100 iu/ml (dose, frequency & route used - 26 iu, qd (8 u in the morning, 10 u at noon and 8 u in the evening) (therapy dates - ongoing) from unknown start date and ongoing for "type 1 diabetes mellitus", tresiba penfill (insulin degludec) solution for injection, 100 iu/ml (dose, frequency & route used - 18 iu, qd (before sleep at night) (therapy dates - ongoing) from unknown start date and ongoing for "type 1 diabetes mellitus." patient's height: 158 cm.Patient's weight: 75 kg.Patient's bmi: 30.04326230.Current condition: type 1 diabetes mellitus (since 2021).Treatment included - rapilin (repaglinide, repaglinide).On an unknown date, patient's novopen 5 memory screen displayed messy words (details not reported).On (b)(6) 2023, patient had diabetic ketoacidosis and was hospitalized due to the event on the same day and her postprandial blood glucose (blood glucose) was 20 mmol/l.The doctor in the hospital prescribed rapilin, used by insulin pump.Details were not provided.Before hospitalization, daily fasting blood glucose(fasting blood glucose) was 6 mmol/l, and postprandial blood glucose (blood glucose) was 11 mmol/l.The patient was discharged on (b)(6) 2023.It was reported that the hospitalization due to diabetic ketoacidosis occured after the memory screen displayed messy words.The needle was replaced after one use.Sometimes the pen was stored with the needle on it.The needle was attached to the pen in a 180 degree angle.The dosage was adjusted according to the dosage indicator.Patient was trained by a health care professional in the use of the novopen.The patient has not changed the novopen 5 to other product.Batch numbers: novopen 5: gvgf879, novopen 5: hvgh885, novorapid penfill: requested, tresiba penfill: requested.Action taken to novorapid penfill was reported as no change.Action taken to tresiba penfill was reported as no change.On (b)(6) 2023, the outcome for the event "ketoacidosis (type 1 diabetes mellitus) (diabetic ketoacidosis)" was recovered.The outcome for the event "memory screen of novopen 5 displayed messy words (device image display issue)" was not reported.The outcome for the event "pen was stored with the needle on it(device stored with needle attached)" was not reported.References included: reference type: e2b company number, reference id#: (b)(4).Reference notes: this report is for a foreign device that is assessed as "similar" to us marketed novopen echo.

• Brand Name: NOVOPEN 5
• Type of Device: INSULIN DELIVERY DEVICE
• Manufacturer (Section D): NOVO NORDISK A/S; bagsvaerd, ; DA
• Manufacturer (Section G): NOVO NORDISK A/S, MEDICAL SYSTEMS; brennum park; hilleroed, 3400 ; DA 3400
• Manufacturer Contact: p.o. box 846; plainsboro, NJ 08536 ; 8007276500
• MDR Report Key: 18156297
• MDR Text Key: 328357978
• Report Number: 9681821-2023-00153
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: K123766
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/19/2020
• Device Model Number: N/A
• Device Lot Number: HVGH885
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2023
• Date Manufacturer Received: 10/23/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/19/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization
• Patient Age: 22 YR
• Patient Sex: Female
• Patient Weight: 75 KG