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

Model Number N/A

Device Problems Inaccurate Flow Rate (1249); Inaccurate Delivery (2339)

Patient Problem Hypoglycemia (1912)

Event Date 01/01/2023

Event Type  Injury  

Event Description

(related symptoms if any separated by commas).Hypoglycaemia [hypoglycaemia].Hypoglycaemia [hypoglycaemia].Piston rods of each novopen 4 injector were moving freely and quickly in and out of the injector.[device delivery system issue].Patient using novopen 4, novorapid insulin was injected at doses that were too high [incorrect dose administered by device].Case description: this serious spontaneous case from poland was reported by a consumer as "hypoglycaemia (hypoglycaemia)" beginning on 2023, "hypoglycaemia (hypoglycaemia)" beginning on (b)(6) 2023, "piston rods of each novopen 4 injector were moving freely and quickly in and out of the injector.(device delivery system improper flow)" with an unspecified onset date, "patient using novopen 4, novorapid insulin was injected at doses that were too high (incorrect dose administered by device)" with an unspecified onset date, and concerned a female patient who was treated with novopen 4 (insulin delivery device) from unknown start date for "device therapy", novopen 4 (insulin delivery device) from unknown start date for "device therapy", novorapid penfill (insulin aspart) (dose, frequency & route used- unk, subcutaneous) from unknown start date and ongoing for "type 1 diabetes mellitus", tresiba penfill 100 u/ml (insulin degludec) (dose, frequency & route used- unk) from unknown start date and ongoing for "type 1 diabetes mellitus".Patient's height, weight and bmi (body mass index) were not reported.Current condition: type 1 diabetes mellitus (since 2001).Treatment included - dextrose.It was reported that the patient has been using tresiba and novorapid for many years.Since the beginning of her diagnosis of type 1 diabetes, the patient has been treated with multiple insulin injections.The patient has been using three novo pen 4 injectors recently.The first events occurred in the summer of 2023 , when novorapid insulin was injected at doses that were too high (and the patient was not aware of that) and the blood sugar level dropped rapidly twice, causing a life-threatening situation, e.G.Severe hypoglycemia events with glucose blood level (blood glucose) of 26 mg and 32 mg which posed the risk of losing consciousness.The patient normalized her sugar levels after taking huge amounts of dextrose (10-15 of carbohydrate exchanges).On (b)(6) 2023, the patient took, as every evening, basal insulin tresiba.After 30 minutes, her glycemia decreased (blood glucose) to 34 mg/dl, so the patient took a very concentrated sugar solution.After an hour her glycemia (blood glucose)was 96 mg/dl, and after 20 minutes it began to decrease again (blood glucose) to 78 mg/dl and 58 mg/dl (there was a time interval of 15 minutes between checks).The patient experienced a significant heart rate increase and felt cold in all her body.She took 5 carbohydrate exchanges of dextrose dissolved in water to increase her blood glucose as quickly as possible.The sugar level (blood glucose) was still very low at 50-60 mg/dl, despite administering so many easily digestible exchangers.So she took another 7 carbohydrate exchangers of dextrose and her sugar level (blood glucose) increased to 75 mg/dl.The patient monitored her blood glucose level on the glucometer and took more sugar to maintain a life-saving glucose level every 40 minutes.The patient also took sugar, dissolved honey, and juices to raise blood sugar levels.On (b)(6) 2023, the patient measured her blood sugar every hour and took additional exchangers.For all day she took only basal insulin tresiba.As these two events occurred during the summer time and at that time the patient was taking in general lower doses of insulin due to the high temperature, patient was sure that too high doses of insulin were not caused by wrong calculations and conversion of the exchangers but for other reasons.The patient took all injectors apart and noticed that piston rods of each novopen 4 injector were moving freely and quickly in and out of the injector, the patient threw all three pens away the patient reported that all novopen 4 injectors she used, had the same problem, e.G.A defective piston rod.According to the patient, this was a very dangerous defect, as patient was not able to identify the problem until the sudden severe, life-threatening hypoglycemia occurred.Batch numbers: novopen 4: mvg6c74-1, mvg8y50-1.Novorapid penfill: asku.Tresiba penfill 100 u/ml: asku.Action taken to novorapid penfill was reported as no change.Action taken to tresiba penfill 100 u/ml was not reported.The outcome for the event "hypoglycaemia(hypoglycaemia)" was recovered.The outcome for the event "hypoglycaemia(hypoglycaemia)" was recovered.The outcome for the event "piston rods of each novopen 4 injector were moving freely and quickly in and out of the injector.(device delivery system improper flow)" was not reported.The outcome for the event "patient using novopen 4, novorapid insulin was injected at doses that were too high(incorrect dose administered by device)" was not reported.Preliminary manufacturer's comment: 13-dec-2023: the suspect device novopen 4 has not been returned to novo nordisk for evaluation.No conclusion reached.Company comment: hypoglycaemia is a listed event according to the novo nordisk current ccds in novorapid penfill and tresiba penfill.This single case report is not considered to change the current knowledge of the safety profile of novorapid penfill and tresiba penfill.

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas).Hypoglycaemia [hypoglycaemia].Hypoglycaemia [hypoglycaemia].Piston rods of each novopen 4 injector were moving freely and quickly in and out of the injector.[device delivery system issue].Patient using novopen 4, novorapid insulin was injected at doses that were too high [incorrect dose administered by device].Defective piston rod [device issue].Feeling cold in all body [feeling cold].Case description: this serious spontaneous case from poland was reported by a consumer as "hypoglycaemia(hypoglycaemia)" beginning on 2023, "hypoglycaemia(hypoglycaemia)" beginning on (b)(6) 2023, "piston rods of each novopen 4 injector were moving freely and quickly in and out of the injector.(device delivery system improper flow)" with an unspecified onset date, "patient using novopen 4, novorapid insulin was injected at doses that were too high(incorrect dose administered by device)" with an unspecified onset date, "defective piston rod(device component defective)" with an unspecified onset date, "feeling cold in all body(feeling cold)" beginning on (b)(6) 2023, and concerned a (age not reported) female patient who was treated with novopen 4 (insulin delivery device) from unknown start date for "device therapy", novopen 4 (insulin delivery device) from unknown start date for "device therapy", , novorapid penfill (insulin aspart) from unknown start date and ongoing for "type 1 diabetes mellitus", , tresiba penfill 100 u/ml (insulin degludec) from unknown start date and ongoing for "type 1 diabetes mellitus".The outcome for the event "hypoglycaemia(hypoglycaemia)" was recovered.The outcome for the event "hypoglycaemia(hypoglycaemia)" was unknown.The outcome for the event "piston rods of each novopen 4 injector were moving freely and quickly in and out of the injector.(device delivery system improper flow)" was not reported.The outcome for the event "patient using novopen 4, novorapid insulin was injected at doses that were too high(incorrect dose administered by device)" was not reported.The outcome for the event "defective piston rod(device component defective)" was not reported.The outcome for the event "feeling cold in all body(feeling cold)" was unknown.Investigation results: novopen 4 - batch mvg6c74-1 no complaint sample was received for investigation; however, a photo of the back side of the pen box was received.The photo was examined but no conclusive investigation could be made based on them.The number of complaints on the batch was evaluated and, when applicable, relevant actions were taken.The product was not returned for examination.Name: novopen 4, batch number: mvg8y50-1 no complaint sample was received for investigation; however, a photo of the back side of the pen box was received.The photo was examined but no conclusive investigation could be made based on them.The number of complaints on the batch was evaluated and, when applicable, relevant actions were taken.The product was not returned for examination.Name: novorapid penfill, batch number: unknown no investigation was possible, because neither sample nor batch number was available.Name: tresiba penfill, batch number: unknown no investigation was possible, because neither sample nor batch number was available.Since last submission the case has been updated with the following information: -new event of 'feeling cold in all body' added -event of 'significant heart rate increase' subsumed under hypoglycemia - action taken updated.-causality updated.-investigation results updated.-annex, b, c d and g codes added.- narrative updated accordingly.Final manufacturer's comment: 23-jan-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.Patient's underlying medical condition of type 1 is a confounding factor for the development of hypoglycaemia.Company comment: hypoglycaemia is assessed as listed event, feeling cold is assessed as unlisted event according to the novo nordisk current ccds in novorapid penfill and tresiba penfill.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 name: novopen 4, batch number: mvg8y50-1.No complaint sample was received for investigation; however, a photo of the back side of the pen box was received.The photo was examined but no conclusive investigation could be made based on them.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: 18433866
• MDR Text Key: 331870849
• Report Number: 9681821-2024-00001
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• Reporter Country Code: PL
• PMA/PMN Number: 20-986
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2024
• 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: MVG8Y50-1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/23/2022
• 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): Life Threatening
• Patient Sex: Female