MAUDE Adverse Event Report: NOVO NORDISK A/S, MEDICAL SYSTEMS NOVOPEN 4; INSULIN DELIVERY DEVICE

Model Number N/A

Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017)

Patient Problem Diabetic Ketoacidosis (2364)

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas) ketoacidosis [ketoacidosis].Cartridge holder was broken.[device breakage] expired device used [expired device used] needle attached to the pen in between injections [product storage error].Case description: study id: 1706-novocare programme study description: trial title: main objective of the programme is to help patients to understand their diabetes and maintain normal life through qualified educators who offer simple and practical information directly to the patients and also, train patients on how to use their insulin devices and needles etc.Patient height, weight, and body mass index was not reported this serious solicited report from egypt was reported by a patient family member or friend as "ketoacidosis(ketoacidosis)" with an unspecified onset date , "cartridge holder was broken.(device breakage)" with an unspecified onset date , "expired device used(expired device used)" with an unspecified onset date , "needle attached to the pen in between injections(device stored with needle attached)" with an unspecified onset date and concerned a patient who was treated with novopen 4 (insulin delivery device) from unknown start date for "device therapy", medical history was not provided.Concomitant medications included - actrapid penfill(insulin human) solution for injection, 100 iu/ml , insulatard penfill(insulin isophane) suspension for injection, 100 iu/ml, lantus(insulin glargine).Actrapid penfill and insulatard penfill were started 6 years ago.On unknown date patient faced ketoacidosis lead the patient to faint and to be hospitalized for one week (i.E., 4 or 5 days in icu and 3 days in hospital) due to an issue in the np4, and by investigation it was found that the cartridge holder was broken before event within 5 days.The patient was treated for ketoacidosis but details were unknown.On unknown date patient used expired device on an unknown date, reported as last wednesday, patient was discharged.No injection of the suspected product into a skin area with lumps and patient hasn't recently switched from another product.The dialling clicks was not used to estimate the dose of the product.The patient in general reuse the needles(unknown name) and was advised to change regularly for every injection.The needle was attached to the pen in between injections.The patient has been changed from another novopen to the current novopen and was using np4.Batch numbers of novopen 4 was dug0347 the outcome for the event "ketoacidosis(ketoacidosis)" was recovered.The outcome for the event "cartridge holder was broken.(device breakage)" was not reported.The outcome for the event "expired device used(expired device used)" was not reported.The outcome for the event "needle attached to the pen in between injections(device stored with needle attached)" was not reported.Reporter's causality (novopen 4) - ketoacidosis(ketoacidosis) : possible cartridge holder was broken.(device breakage) : possible expired device used(expired device used) : unknown needle attached to the pen in between injections(device stored with needle attached) : unknown company's causality (novopen 4) - ketoacidosis(ketoacidosis) : possible cartridge holder was broken.(device breakage) : possible expired device used(expired device used) : possible needle attached to the pen in between injections(device stored with needle attached) : possible references included: reference type: e2b company number reference id#: (b)(4).

Event Description

Case description: investigation result: novopen 4 - batch dug0347.The number of complaints on the batch was evaluated and, when applicable, relevant actions were taken.The product was not returned for examination.Since last submision, the case has been updated with the following information: -investigation results updated.-imdrf codes updated.-narrative updated accordingly.Final manufacturer's comment: 30-jan-2024: the suspected device novopen 4 has not been returned to novo nordisk for evaluation.No abnormalities relating to the observed problem were found in the reference sample analysis.The batch documentation has been reviewed and found to be normal.With the available limited information regarding the handling of the suspected device, it is not possible to identify a clear root cause in relation to functionality of novopen 4.However, use of expired device and product handling error such as storing the device with needle attached can affect the functionality of novopen 4.H3 continued: evaluation summary: novopen 4 - batch dug0347.The number of complaints on the batch was evaluated and, when applicable, relevant actions were taken.The product was not returned for examination.

• Brand Name: NOVOPEN 4
• Type of Device: INSULIN DELIVERY DEVICE
• Manufacturer (Section D): NOVO NORDISK A/S, MEDICAL SYSTEMS; hilleroed,, ; 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: 18397289
• MDR Text Key: 331368616
• Report Number: 9681821-2023-00182
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: 20-986
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/14/2016
• Device Model Number: N/A
• Device Catalogue Number: 185490
• Device Lot Number: DUG0347
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2014
• 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
• Treatment: ACTRAPID PENFILL (INSULIN HUMAN); INSULATARD PENFILL (INSULIN ISOPHANE); LANTUS (INSULIN GLARGINE)
• Patient Outcome(s): Hospitalization; Other