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

Model Number N/A

Device Problem Inaccurate Delivery (2339)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912); Coma (2417)

Event Date 12/10/2023

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas) pen does not deliver accurate doses [device delivery system issue] hyperglycemic coma [diabetic hyperglycaemic coma] hypoglycemia [hypoglycaemia] case description: study id: (b)(6) 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.This serious solicited report from egypt was reported by a patient family member or friend as "pen does not deliver accurate doses(inaccurate delivery by device)" with an unspecified onset date , "hyperglycemic coma(hyperglycemic coma)" with an unspecified onset date , "hypoglycemia(hypoglycemia)" beginning on (b)(6) 2023 and concerned a 12 years old female patient who was treated with novopen 4 (insulin delivery device) from unknown start date for "device therapy", , novorapid penfill (insulin aspart) (dose, frequency & route used-unk(without regular doses, regimen #2: 2 iu(only if bgl became is higher than 300 mg/dl mr7jl80 04/--/2025 and regimen #3: 3 or 4 iu(the bgls still high after meals mr7jl80 04/--/2025)))) from unknown start date for "product used for unknown indication", , tresiba penfill (insulin degludec) (dose, frequency & route used- 12 iu, qd(at night)) from unknown start date for "product used for unknown indication", dosage regimens: novopen 4: novorapid penfill: tresiba penfill: current condition: type 1 diabetes.Current condition: type 1 diabetes mellitus(since 1 years and 2 months ago) on an unknown date, the patient and patient's mother complained that the pen did not deliver accurate doses, and that caused the patient to fall into hyperglycemic coma 3 times when rbgls were very high on the bgm (no measurements appeared): 1st one was 1 year and 2 months ago when patient was diagnosed with dm for 1st time, 2nd on (b)(6) 2023 treated iv solutions (as per reporter's word) during hospitalization for 10 days and 3rd on (b)(6) 2023 treated also by iv solutions during hospitalization for 9 days and all of hyperglycemic coma as completely recovered since discharging from hospitalization of (b)(6) 2023 on (b)(6) 2023, the patient experienced hypoglycemia since discharging from hospital.The patient hospitalized again at the last of dec-2023 till 03 or (b)(6) 2024 (she could not confirm exact discharge day, but there were 8 or 9 days in the hospital) due to hypoglycemia.There were not any changes in patient's physical or motor skills or mental or pubertal developments.- suspected np4 started 1 years and 2 months but replaced since ird and the other np4 used with tresiba penfill started to be used 3 or 4 months ago and only numbers at the dose screen are used for dose estimation.The needle is usually attached to the pen in a 180 degree angle.Patient was not using any concomitant medications.On an unknown date, the patient's random blood glucose (blood glucose ) was high(results and units not reported).On an unknown date, the patient's random blood glucose (blood glucose ) was 40 or 45mg/dl specially at dawn.Batch numbers: novopen 4: novorapid penfill:mr7jl80 tresiba penfill: ns6hw41; action taken to novorapid penfill was not reported.Action taken to tresiba penfill was not reported.The outcome for the event "pen does not deliver accurate doses(inaccurate delivery by device)" was not reported.On (b)(6) 2023 the outcome for the event "hyperglycemic coma(hyperglycemic coma)" was recovered.The outcome for the event "hypoglycemia(hypoglycemia)" was not yet recovered.Reporter's causality (novopen 4) - pen does not deliver accurate doses(inaccurate delivery by device) : unknown hyperglycemic coma(hyperglycemic coma) : unknown hypoglycemia(hypoglycemia) : unknown company's causality (novopen 4) - pen does not deliver accurate doses(inaccurate delivery by device) : possible hyperglycemic coma(hyperglycemic coma) : possible hypoglycemia(hypoglycemia) : possible reporter's causality (novorapid penfill) - pen does not deliver accurate doses(inaccurate delivery by device) : unknown hyperglycemic coma(hyperglycemic coma) : unknown hypoglycemia(hypoglycemia) : unknown company's causality (novorapid penfill) - pen does not deliver accurate doses(inaccurate delivery by device) : possible hyperglycemic coma(hyperglycemic coma) : possible hypoglycemia(hypoglycemia) : possible reporter's causality (tresiba penfill) - pen does not deliver accurate doses(inaccurate delivery by device) : unknown hyperglycemic coma(hyperglycemic coma) : unlikely hypoglycemia(hypoglycemia) : unlikely company's causality (tresiba penfill) - pen does not deliver accurate doses(inaccurate delivery by device) : possible hyperglycemic coma(hyperglycemic coma) : possible hypoglycemia(hypoglycemia) : possible references included: reference type: e2b company number reference id#: (b)(4).

Event Description

Case description: investigational results : novopen 4 batch number - mvg8e51.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 submission the case has been updated with the following: investigational results were updates.B,c,d,g coded were updated.Malfunction was updated.Narrative updated accordingly.References included: reference type: e2b company number.Reference id#: eg-novoprod-1160778.Reference notes: reference type: mw 3500a mfr.Rpt.#.Reference id#: 9681821-2024-00021.Reference notes: medwatch 3500a mfr.Report number.Final manufacturer's comment: 19-apr-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.Events are listed.This single case report is not considered to change the current knowledge of the safety profile of novorapid penfill and tresiba penfill.H3 continued: evaluation summary.Novopen 4 batch number - mvg8e51.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: 18604848
• MDR Text Key: 334025932
• Report Number: 9681821-2024-00021
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• 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: 01/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: N/A
• Device Catalogue Number: 185490
• Device Lot Number: MVG8E51
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2022
• 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): Hospitalization; Other
• Patient Age: 12 YR
• Patient Sex: Female