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

Model Number N/A

Device Problems Break (1069); Failure to Deliver (2338); Device Fell (4014)

Patient Problems Hypoglycemia (1912); Coma (2417)

Event Type  Injury  

Event Description

(related symptoms if any separated by commas).Coma due to hypoglycaemia [hypoglycaemic coma].Novopen4 fell [device physical property issue].Novopen4 was broken at the penfill holder's side [device breakage].Blood drops appeared at the injection site [injection site haemorrhage].The pen did not inject the insulin [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 (bmi) were not reported.This serious solicited report from egypt was reported by a consumer as "coma due to hypoglycaemia(hypoglycaemic coma)" with an unspecified onset date , "novopen4 fell(device damage)" with an unspecified onset date , "novopen4 was broken at the penfill holder's side(device breakage)" with an unspecified onset date , "blood drops appeared at the injection site(injection site bleeding)" with an unspecified onset date , "the pen did not inject the insulin(device failure)" with an unspecified onset date and concerned a male patient who was treated with novopen 4 (insulin delivery device) from unknown start date for "diabetes mellitus", novorapid penfill (insulin aspart) solution for injection, 100 iu/ml (dose, frequency & route used - 34 iu, qd, subcutaneous) (therapy dates - unk to (b)(6) 2022) from unknown start date to (b)(6) 2022 for "diabetes mellitus", current condition: diabetes mellitus (type and duration not reported).Concomitant medications included - toujeo(insulin glargine).On an unspecified date, patient had a coma due to hypoglycemia " bg level was 70 mg/dl".The patient felt dizziness, shivering and hard breathing then became unconscious for only 10 min.On (b)(6) 2022 patient became conscious again after drinking a juice and neither intervention nor treatment required.It was reported that the patient's novopen4 fell.Novopen was broken at the penfill holder's side which affected the attaching of the penfill holder from the mechanical part after falling down.Novopen was not used after the event and replaced by syringe " the pen was not replaced by the ncc as at the time of direction for replacing as patient was shifted to humulin since (b)(6) 2022 not due to any event with novorapid with which patient feels good in general, but as novorapid is not available to be received from patient's health insurance.It was reported that sometimes " the pen did not inject the insulin and blood drops appeared at the injection site and that recovered once the pen's parts detached and reattached again.Batch numbers of novopen 4 was requested.Novorapid penfill: mr7cl9.Action taken to novopen 4 was not reported.Action taken to novorapid penfill was reported as product discontinued.The outcome for the event "coma due to hypoglycaemia(hypoglycaemic coma)" was not reported.The outcome for the event "novopen4 fell(device damage)" was not reported.The outcome for the event "novopen4 was broken at the penfill holder's side(device breakage)" was not reported.The outcome for the event "blood drops appeared at the injection site(injection site bleeding)" was recovered.The outcome for the event "the pen did not inject the insulin(device failure)" was not reported.Reporter's causality (novopen 4) - coma due to hypoglycaemia(hypoglycaemic coma) : unknown.Novopen4 fell(device damage) : unknown.Novopen4 was broken at the penfill holder's side(device breakage) : unknown.Blood drops appeared at the injection site(injection site bleeding) : unknown.The pen did not inject the insulin(device failure) : unknown.Company's causality (novopen 4) - coma due to hypoglycaemia(hypoglycaemic coma) : possible.Novopen4 fell(device damage) : possible.Novopen4 was broken at the penfill holder's side(device breakage) : possible.Blood drops appeared at the injection site(injection site bleeding) : possible.The pen did not inject the insulin(device failure) : possible.Reporter's causality (novorapid penfill) - coma due to hypoglycaemia(hypoglycaemic coma) : unknown.Novopen4 fell(device damage) : unknown.Novopen4 was broken at the penfill holder's side(device breakage) : unknown.Blood drops appeared at the injection site(injection site bleeding) : unknown.The pen did not inject the insulin(device failure) : unknown.Company's causality (novorapid penfill) - coma due to hypoglycaemia(hypoglycaemic coma) : possible.Novopen4 fell(device damage) : possible.Novopen4 was broken at the penfill holder's side(device breakage) : possible.Blood drops appeared at the injection site(injection site bleeding) : possible.The pen did not inject the insulin(device failure) : possible.Preliminary manufacturer's comment: 04-aug-2022: the suspected device novopen 4 has not been returned to novo nordisk for evaluation.No conclusion is reached.Patient is a trained user of the device novopen 4.The device was broken at cartridge holder after falling down.The reported device issue could be related incorrect handling of the device.Company comment: hypoglycaemic coma and injection site haemorrhage are assessed as listed event according to the novo nordisk current ccds in novorapid penfill.Relevant information on medical history, diet and lifestyle, product administration training, concomitant medication, final diagnosis, action taken and outcome of the event are unavailable for complete causality assessment.The device was broken at cartridge holder after falling down.The reported device issue could be related incorrect handling of the device.This single case report is not considered to change the current knowledge of the safety profile of novorapid penfill.

Event Description

Case description: investigation result: name : novopen® 4 batch number: unknown.No investigation was possible, because neither sample nor batch number was available.Investigation result: name : novorapid penfill 4 batch number: mr7cl9 the product was not returned for examination.No additional corrective or preventive actions implemented/required.General complaint surveillance applies.Since last submission, the following information was added.-investigation result updated.-device tab, eu/ca tab, device addendum tab updated.-narrative updated accordingly.Final manufacturer's comment: 16-sep-2022: the suspected device novopen 4 has not been returned to novo nordisk for evaluation.Batch number of devices is not available despite repeated efforts find the same.Batch trend analysis or reference sample analysis was not performed.Patient is a trained user of the device novopen 4.However, the device was broken at cartridge holder after device fell on floor.The reported device issue could be related incorrect handling of the device.Company comment: hypoglycaemic coma and injection site haemorrhage are assessed as listed event according to the novo nordisk current ccds in novorapid penfill.Relevant information on medical history, diet and lifestyle, product administration training, concomitant medication, final diagnosis, action taken, and outcome of the event are unavailable for complete causality assessment.The device was broken at cartridge holder after fell on floor.The reported device issue could be related incorrect handling of the device.This single case report is not considered to change the current knowledge of the safety profile of novorapid penfill.H3 continued: evaluation summary: investigation result: name : novopen® 4 batch number: unknown no investigation was possible, because neither sample nor batch number was available.No additional corrective or preventive actions implemented/required.General complaint surveillance applies.

• 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: 15245189
• MDR Text Key: 298114081
• Report Number: 9681821-2022-00068
• 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: 07/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 185490
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/24/2022
• Initial Date FDA Received: 08/17/2022
• Supplement Dates Manufacturer Received: 09/12/2022
• Supplement Dates FDA Received: 10/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: TOUJEO (INSULIN GLARGINE).
• Patient Outcome(s): Other; Life Threatening
• Patient Sex: Male