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

Model Number N/A

Device Problem Defective Device (2588)

Patient Problems Hyperglycemia (1905); Diabetic Ketoacidosis (2364)

Event Date 06/20/2021

Event Type  Injury  

Event Description

Increased acetone levels [blood ketone body increased].Novopen 4 does not push insulin [device malfunction].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.The patient's height, weight and body mass index was not reported.This serious solicited report from (b)(6) was reported by a consumer as "increased glucose levels (blood sugar increased)" beginning on (b)(6) 2021, "increased acetone levels (acetone increased)" beginning on (b)(6) 2021, "novopen 4 does not push insulin(device malfunction)" beginning on (b)(6) 2021 and concerned a (b)(6) years old female patient who was treated with novopen 4 (insulin delivery device) from unknown start date for "type 1 diabetes", , novorapid penfill (insulin aspart) solution for injection, 100 iu/ml from unknown start date for "type 1 diabetes", dosage regimens: novopen 4: not reported.Novorapid penfill: not reported.Current condition: type 1 diabetes (duration not reported).Concomitant medications included - lantus(insulin glargine).It was reported that on (b)(6) 2021, novopen 4 did not push insulin, that lead to increased glucose and acetone levels and patient entered in intensive care unit (icu) on an unspecified date.Batch numbers: novopen 4: hvgl468.Novorapid penfill: asku; action taken to novopen 4 was reported as product discontinued due to ae.Action taken to novorapid penfill was not reported.On (b)(6) 2021 the outcome for the event "increased glucose levels(blood sugar increased)" was recovered.On (b)(6) 2021 the outcome for the event "increased acetone levels(acetone increased)" was recovered.The outcome for the event "novopen 4 does not push insulin(device malfunction)" was not reported.Reporter's causality (novopen 4) - increased glucose levels(blood sugar increased) : probable.Increased acetone levels(acetone increased) : probable.Novopen 4 does not push insulin(device malfunction) : probable.Company's causality (novopen 4) - increased glucose levels(blood sugar increased) : possible.Increased acetone levels(acetone increased) : possible.Novopen 4 does not push insulin(device malfunction) : possible.Reporter's causality (novorapid penfill) - increased glucose levels (blood sugar increased) : unlikely.Increased acetone levels(acetone increased) : unlikely.Novopen 4 does not push insulin(device malfunction) : unlikely.Company's causality (novorapid penfill) - increased glucose levels(blood sugar increased) : possible.Increased acetone levels(acetone increased) : possible.Novopen 4 does not push insulin(device malfunction) : possible.Preliminary manufacturer's comment: (b)(6) 2021: the suspected device (novopen 4) has not been returned to novo nordisk for evaluation.No conclusion is reached.Company comment: blood glucose increased and blood ketone bodies increased are assessed as listed according to the novo nordisk current ccds in novorapid penfill.Relevant information on acute infection, device and suspected product investigation results are unavailable for complete causality assessment.Patient's underlying medical condition of type 1 diabetes mellitus is a significant risk factor for the development of reported diabetic ketoacidosis.This single case report is not considered to change the current knowledge of the safety profile of novorapid penfill.

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas) case description: investigational results: novopen 4 - batch (b)(6).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 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.Novorapid penfill 3 ml 100iu/ml - batch unknown.No investigation was possible, because neither sample nor batch number was available.Since last submission the case has been updated with the following investigational results updated.Imdrf codes has been updated.Is non-reportable has been updated.Malfunction, device available for evaluation has been updated.Narrative updated accordingly.Final manufacturer's comment: (b)(6) 2021: the suspected device (novopen 4) has been returned to novo nordisk for evaluation.Investigation of the device showed that it was working in accordance to specifications.Since no faults were found on the returned device 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 event of hyperglycaemia and ketone bodies increased.Patient's underlying medical condition of type 1 diabetes mellitus is a significant risk factor for the development of reported diabetic ketoacidosis.Company comment: blood glucose increased and blood ketone bodies increased are assessed as listed according to the novo nordisk current ccds in novorapid penfill.Relevant information on acute infection, stress or trauma are unavailable for complete causality assessment.Investigation of the device showed that it was working in accordance to specifications.The suspected product (novorapid penfill) has not been returned for evaluation.Patient's underlying medical condition of type 1 diabetes mellitus is a significant risk factor for the development of reported diabetic ketoacidosis.This single case report is not considered to change the current knowledge of the safety profile of novorapid penfill.H3 continued: evaluation summary: novopen 4 - batch (b)(6).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 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
• MDR Report Key: 12201671
• MDR Text Key: 269799961
• Report Number: 9681821-2021-00040
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• PMA/PMN Number: 20-986
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,study
• Type of Report: Initial,Followup
• Report Date: 07/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/26/2023
• Device Model Number: N/A
• Device Catalogue Number: 185490
• Device Lot Number: HVGL468
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2021
• Date Manufacturer Received: 09/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LANTUS (INSULIN GLARGINE)
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 9 YR