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

Model Number N/A

Device Problems Improper or Incorrect Procedure or Method (2017); Defective Device (2588); Device Handling Problem (3265)

Patient Problems Diabetic Ketoacidosis (2364); Injection Site Reaction (4562)

Event Date 06/29/2023

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas).Suffered from hyperglycemia due to np4 and that lead to hospitalization and acidosis [diabetic ketoacidosis] gap between the piston rod head and cartilage back [device issue] caused lumps formation at injection site reaction [injection site mass] used the dialling clicks to estimate the dose of the product [wrong technique in device usage process].Preserved in refrigerator with the needle in between injection [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's weight: 46 kg.Patient's height, and body mass index (bmi) were not reported.This serious solicited report from egypt was reported by a consumer as "suffered from hyperglycemia due to np4 and that lead to hospitalization and acidosis(diabetic acidosis)" beginning on (b)(6) 2023 , "gap between the piston rod head and cartilage back(device issue)" with an unspecified onset date , "caused lumps formation at injection site reaction(injection site lump)" with an unspecified onset date, "used the dialling clicks to estimate the dose of the product(wrong technique in device usage process)" with an unspecified onset date , "preserved in refrigerator with the needle in between injection(improper storage of product in use)" with an unspecified onset date and concerned a 12 years old female patient who was treated with novopen 4 (insulin delivery device) from unknown start date for "diabetes mellitus", current condition: diabetes mellitus (type and duration: not reported), vit d deficiency, anaemia.Historical condition: loss of conscious procedure: hospitalization.Concomitant medications included - actrapid (insulin human 100 iu/ml) solution for injection, 100 iu/ml on (b)(6) 2023, the patient suffered from hyperglycemia due to np4 device issue(gap between the piston rod head and cartilage back) and that lead to hospitalization and acidosis (diabetic acidosis), the event lasted only for one day.(dischage date was unspecified).Patient received i/v solution and discharged after 48 hrs and acetone still not yet recovered and in home advised to drink plenty amount of water patient hba1c (glycosylated haemoglobin) was 6.4% patient felt force needed to inject needle was different from normal(easier)and caused lumps formation at injection site reaction, patient used a clear insulin not mix before usage, she used the dialling clicks to estimate the dose of the product, patient was trained by a health care professional in the use of the novopen, patient did not change any recent in diet or exercise level, the needle attached to the pen in a 180 degree angle (straight on) and in general reuse the needle, patient insulin in used was not preserved at room temperature 20-25 degrees celsius its preserved in refrigerator with the needle in between injection, patient confirmed cartridge holder didn't detach from the pen body accidentally or intent.On (b)(6) 2023 , patient recently changed from another novopen to the current novopen and event not yet recovered on the current np4 and the event disapear with mixtard 30 vials with syringes.Patient was advised to do needle cap trial as the event didn't occur with the same doses with vials by syringes and she confirmed that she will do that later on.Batch numbers: novopen 4: hvgn506.The outcome for the event "suffered from hyperglycemia due to np4 and that lead to hospitalization and acidosis(diabetic acidosis)" was not yet recovered.The outcome for the event "gap between the piston rod head and cartilage back(device issue)" was not reported.The outcome for the event "caused lumps formation at injection site reaction(injection site lump)" was not reported.The outcome for the event "used the dialling clicks to estimate the dose of the product(wrong technique in device usage process)" was not reported.The outcome for the event "preserved in refrigerator with the needle in between injection(improper storage of product in use)" was not reported.Reporter's causality (novopen 4).Suffered from hyperglycemia due to np4 and that lead to hospitalization and acidosis(diabetic acidosis) : probable gap between the piston rod head and cartilage back(device issue) : unknown.Caused lumps formation at injection site reaction(injection site lump) : unknown.Used the dialling clicks to estimate the dose of the product(wrong technique in device usage process) : unknown.Preserved in refrigerator with the needle in between injection(improper storage of product in use) : unknown.Company's causality (novopen 4).Suffered from hyperglycemia due to np4 and that lead to hospitalization and acidosis(diabetic acidosis) : possible.Gap between the piston rod head and cartilage back(device issue) : possible.Caused lumps formation at injection site reaction(injection site lump) : possible.Used the dialling clicks to estimate the dose of the product(wrong technique in device usage process) : possible.Preserved in refrigerator with the needle in between injection(improper storage of product in use) : possible.Preliminary manufacturer's comment: (b)(6) 2023: the suspected device novopen 4 has not yet been returned to examine if it works according to set specifications and intended use.No conclusion is reached.Product handling error such as improper storage of device, needle reusage and wrong technique in device use can affect the functionality of device.References included: reference type: e2b company number.Reference id#: (b)(4).Reference notes: reference type: e2b linked report.Reference id#: (b)(4).Reference notes: linked case.Reporter comment: patient discharged after 48 hr (viral infection common cold and feverish).

Event Description

Case description: investigational results: name: novopen 4; batch number:hvgn506 visual examination and functional testing were performed.The device was tested with a random cartridge and a novo nordisk needle was mounted.During testing it was possible to deliver preparation from the cartridge.The number of complaints on the batch was evaluated and, when applicable, relevant actions were taken.The dose accuracy was measured by weighing using a random cartridge.The results were found to comply with specifications.During examination of the product, no irregularities related to the complaint were detected.Since last submission the case has been updated with the following: invesitigational results were updated.Relevant fields updated in eu/ca tab, device available for evaluation was updated, malfunction field changed to no, imdrf codings were updated, narrative was updated accordingly final manufacturer's comment: 21-sep-2023: the suspected device novopen 4 has been returned to novo nordisk for evaluation.Upon investigation, device was found to be working as intended, no abnormalities detected.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.Since no faults were found on the returned device novopen 4 and only very limited information regarding the patients handling of the suspected device is reported in the case, it is not possible to elucidate a clear root cause for the experienced adverse events.However, patient is a kid (12 years) and underlying type 1 diabetes mellitus are considered as confounding factors for development of hyperglycaemia.H3 continued: evaluation summary name: novopen 4; batch number:hvgn506 visual examination and functional testing were performed.The device was tested with a random cartridge and a novo nordisk needle was mounted.During testing it was possible to deliver preparation from the cartridge.The number of complaints on the batch was evaluated and, when applicable, relevant actions were taken.The dose accuracy was measured by weighing using a random cartridge.The results were found to comply with specifications.During examination of the product, no irregularities related to the complaint were detected.

• 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: 17508098
• MDR Text Key: 320862729
• Report Number: 9681821-2023-00110
• 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: 07/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 11/03/2023
• Device Model Number: N/A
• Device Catalogue Number: 185490
• Device Lot Number: HVGN506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 09/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2018
• 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
• Treatment: ACTRAPID (INSULIN HUMAN 100 IU/ML)
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 12 YR
• Patient Sex: Female
• Patient Weight: 46 KG