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

Model Number N/A

Device Problem Failure to Deliver (2338)

Patient Problems Diabetic Ketoacidosis (2364); Coma (2417)

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas), diabetic patient had coma because of ketoacidosis [diabetic ketoacidotic hyperglycaemic coma], novopen4 didn't push insulin for a week which led to coma because of ketoacidosis [device failure].Case description: study id: (b)(6).Study description: 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 were not reported.This serious solicited report from egypt was reported by a consumer as "diabetic patient had coma because of ketoacidosis(diabetic ketoacidotic hyperglycaemic coma)" with an unspecified onset date , "novopen4 didn't push insulin for a week which led to coma because of ketoacidosis(device failure)" with an unspecified onset date and concerned a (b)(6) years old male patient who was treated with novopen 4 (insulin delivery device) from unknown start date for "diabetes mellitus", , actrapid penfill (insulin human) solution for injection, 100 iu/ml, dose, frequency & route used- 13iu, subcutaneous from unknown start date and ongoing for "diabetes mellitus", insulatard penfill (insulin human) suspension for injection, 100 iu/ml, dose, frequency & route used- 12 iu, subcutaneous from unknown start date and ongoing for "diabetes mellitus".Dosage regimens: novopen 4: unk, actrapid penfill: 13iu, insulatard penfill: 12iu.Current condition: diabetes mellitus (type and duration not reported).It was reported that novopen4 didn't push insulin for a week which led to coma because of ketoacidosis in a diabetic patient.The patient stopped using novopen 4.So patient used the syringe to take the dose instead of using novopen 4.Reporter was taught how to adjust the piston.Batch numbers: novopen 4: cug2275, actrapid penfill: gr78051, insulatard penfill: asku.Action taken to novopen 4 was product discontinued.Action taken to actrapid penfill was not reported.Action taken to insulatard penfill was not reported.The outcome for the event "diabetic patient had coma because of ketoacidosis(diabetic ketoacidotic hyperglycaemic coma)" was not reported.The outcome for the event "novopen4 didn't push insulin for a week which led to coma because of ketoacidosis(device failure)" was not reported.Reporter's causality (novopen 4) - diabetic patient had coma because of ketoacidosis(diabetic ketoacidotic hyperglycaemic coma) : probable.Novopen4 didn't push insulin for a week which led to coma because of ketoacidosis(device failure) : probable.Company's causality (novopen 4) - diabetic patient had coma because of ketoacidosis(diabetic ketoacidotic hyperglycaemic coma) : possible.Novopen4 didn't push insulin for a week which led to coma because of ketoacidosis(device failure) : possible.Reporter's causality (actrapid penfill) - diabetic patient had coma because of ketoacidosis(diabetic ketoacidotic hyperglycaemic coma) : unlikely.Novopen4 didn't push insulin for a week which led to coma because of ketoacidosis(device failure) : unlikely.Company's causality (actrapid penfill) - diabetic patient had coma because of ketoacidosis(diabetic ketoacidotic hyperglycaemic coma) : possible.Novopen4 didn't push insulin for a week which led to coma because of ketoacidosis(device failure) : possible.Reporter's causality (insulatard penfill) - diabetic patient had coma because of ketoacidosis(diabetic ketoacidotic hyperglycaemic coma) : unlikely.Novopen4 didn't push insulin for a week which led to coma because of ketoacidosis(device failure) : unlikely.Company's causality (insulatard penfill) - diabetic patient had coma because of ketoacidosis(diabetic ketoacidotic hyperglycaemic coma) : possible.Novopen4 didn't push insulin for a week which led to coma because of ketoacidosis(device failure) : possible.In order to protect the safety of patient it will, in rare cases, be required to disassemble the medical device immediately in a way where it is not subsequently possible to reassemble it (e.G.Destructive testing or altering of the medical device).The disassembled medical device will be stored with the same retention period as other complaint samples.Preliminary manufacturer's comment: on (b)(6) 2021: the suspected device (novopen 4) has not been retuned to novo nordisk for evaluation.No conclusion reached.Considering that reporter was taught how to adjust the piston, device failure could be related to product training issues.Company comment: diabetic ketoacidotic hyperglycaemia coma is assessed as listed according to the novo nordisk current ccds in actrapid and insulatard.Patient's age ((b)(6) years) and underlying diabetes and wrong technique in product usage process are significant confounding factors for the development of diabetic ketoacidotic hyperglycaemic coma.This single case report is not considered to change the current knowledge of the safety profile of actrapid and insulatard.

Event Description

Case description: it was reported that patient stopped using novopen4 5 years ago and is just afraid of using it again.Investigation results name: novopen® 4 - batch cug2275 the product was not returned for examination.No investigation was possible, because sample was not available.Name: actrapid® penfill® 3 ml 100iu/ml - batch gr78051 the product was not returned for examination.No investigation was possible, because sample was not available.Name: insulatard® penfill® 3 ml 100iu/ml - batch unknown the product was not returned for examination.No investigation was possible, because neither sample nor batch number was available.Since last submission, the following information has been updated: -investigation results updated.-annex b, c, d and g codes updated.-manufacturer's comment updated.-narrative updated with 'it was reported that patient stopped using novopen4 5 years ago and is just afraid of using it again'.-narrative updated accordingly.Final manufacturer's comment: 15-feb-2021: the suspected device novopen 4 has not been returned to novo nordisk for evaluation.Considering that reporter was taught how to adjust the piston, device failure could be related to product training issues.With limited information regarding the handling of suspected device, it is not possible to identify a clear root-cause of the experienced adverse event.Patient's underlying medical condition of type 1 diabetes mellitus is a significant confounding factor for the development of diabetic ketoacidosis.Company comment: diabetic ketoacidotic hyperglycaemia coma is assessed as listed according to the novo nordisk current ccds in actrapid and insulatard.Patient's age (13 years), underlying type 1 diabetes mellitus and wrong technique in product usage process are significant confounding factors for the development of diabetic ketoacidotic hyperglycaemic coma.This single case report is not considered to change the current knowledge of the safety profile of actrapid and insulatard.H3 continued: evaluation summary investigation results name: novopen® 4 - batch cug2275 the product was not returned for examination.No investigation was possible, because sample was not available.

Event Description

Case description: this serious solicited report from egypt was reported by a consumer as "diabetic patient had coma because of ketoacidosis(diabetic ketoacidotic hyperglycaemic coma)" with an unspecified onset date , "novopen4 didn't push insulin for a week which led to coma because of ketoacidosis(device failure)" with an unspecified onset date and concerned a 13 years old male patient who was treated with novopen 4 (insulin delivery device) from unknown start date for "diabetes mellitus", novopen 4 (insulin delivery device) from unknown start date for "diabetes mellitus", actrapid penfill (insulin human) from unknown start date and ongoing for "diabetes mellitus", insulatard penfill (insulin human) from unknown start date and ongoing for "diabetes mellitus".Batch numbers: novopen 4: cug2275.Novopen 4: cug2275.Insulatard penfill: unknown; action taken to novopen 4 was product discontinued.Action taken to novopen 4 was product discontinued.Reporter's causality (novopen 4) - diabetic patient had coma because of ketoacidosis(diabetic ketoacidotic hyperglycaemic coma) : probable.Novopen4 didn't push insulin for a week which led to coma because of ketoacidosis(device failure) : probable.Company's causality (novopen 4) - diabetic patient had coma because of ketoacidosis(diabetic ketoacidotic hyperglycaemic coma) : possible.Novopen4 didn't push insulin for a week which led to coma because of ketoacidosis(device failure) : possible.Reporter's causality (novopen 4) - diabetic patient had coma because of ketoacidosis(diabetic ketoacidotic hyperglycaemic coma) : probable.Novopen4 didn't push insulin for a week which led to coma because of ketoacidosis(device failure) : probable.Company's causality (novopen 4) - diabetic patient had coma because of ketoacidosis(diabetic ketoacidotic hyperglycaemic coma) : possible.Novopen4 didn't push insulin for a week which led to coma because of ketoacidosis(device failure) : possible.Investigation results name: novopen® 4 - batch cug2275.The product was not returned for examination.No investigation was possible, because sample was not available.Novopen 4, batch number: cug2275 the product was not returned for examination.If possible, please forward the reported product(s) for further investigations.Name: actrapid® penfill® 3 ml 100iu/ml - batch gr78051.The product was not returned for examination.No investigation was possible, because sample was not available.Name: insulatard® penfill® 3 ml 100iu/ml - batch unknown.The product was not returned for examination.No investigation was possible, because neither sample nor batch number was available.On (b)(6) 2021, a correction had been performed.It was reported that patient used 2 "novopen 4" pens with the same batch number.Hence additional novopen 4 had been added as a suspect device which was missed to be captured in the initial case and resubmitted.Since last submission, the following information has been updated: -novopen 4 updated as suspect product.-investigation results updated.-manufacturer comment updated -narrative updated accordingly.Final manufacturer's comment: (b)(6) 2021: the suspected device novopen 4 has not been returned to novo nordisk for evaluation.Considering that reporter was taught how to adjust the piston, device failure could be related to product training issues.With limited information regarding the handling of suspected device, it is not possible to identify a clear root-cause of the experienced adverse event.Patient's underlying medical condition of type 1 diabetes mellitus is a significant confounding factor for the development of diabetic ketoacidosis.Company comment: diabetic ketoacidotic hyperglycaemia coma is assessed as listed according to the novo nordisk current ccds in actrapid and insulatard.Patient's age (13 years), underlying type 1 diabetes mellitus and wrong technique in product usage process are significant confounding factors for the development of diabetic ketoacidotic hyperglycaemic coma.This single case report is not considered to change the current knowledge of the safety profile of actrapid and insulatard.References included: reference type: e2b company number.Reference id#: (b)(4).Reference notes: reference type: mw 3500a mfr.Rpt.#.Reference id#: (b)(4).Reference notes: medwatch 3500a mfr.Report number.

• Brand Name: NOVOPEN 4
• Type of Device: INSULIN DELIVERY DEVICE
• Manufacturer (Section D): NOVO NORDISK A/S, MEDICAL SYSTEMS; hilleroed, ; DA
• MDR Report Key: 11307055
• MDR Text Key: 238863333
• Report Number: 9681821-2021-00009
• 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,Followup
• Report Date: 01/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2015
• Device Model Number: N/A
• Device Catalogue Number: 185490
• Device Lot Number: CUG2275
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 13 YR