MAUDE Adverse Event Report: NOVO NORDISK A/S NOVOPEN 6; INSULIN DELIVERY DEVICE

Model Number N/A

Device Problems Defective Component (2292); Inaccurate Delivery (2339)

Patient Problem Hyperglycemia (1905)

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas).Blood sugars of 27+ [blood glucose increased].Plunger problem each time [device issue].Plunger problem each time, the required insulin dose is not been delivered [device delivery system issue].Case description: this serious spontaneous case from the united kingdom was reported by a consumer as "blood sugars of 27+(blood sugar increased)" with an unspecified onset date, "plunger problem each time(device component issue)" with an unspecified onset date, "plunger problem each time, the required insulin dose is not been delivered(inaccurate delivery by device)" with an unspecified onset date, and concerned a (age and gender not reported) patient who was treated with novopen 6 (insulin delivery device) from unknown start date for "device therapy", , novopen (insulin delivery device) from unknown start date for "device therapy." patient's height, weight and body mass index was not reported.Dosage regimens: novopen 6: novopen: current condition: type 1 diabetic.(duration not reported): on an unknown date, patient reported having issues with 2 of their novopens (novopen 6 blue, novopen) as they were not delivering the right amount of insulin.Patient thought that it was a plunger problem and each time the required insulin dose had not been delivered.This had resulted in an unacceptable, really dangerous level of blood sugars (blood glucose), which is 27+ (units not reported) and ended up with a hospital admission (other details and duration of hospitalization were not reported).Batch number for novopen 6 was mvg8g82.Batch number for novopen was not reported.Action taken to novopen 6 was not reported.The outcome for the event "blood sugars of 27+(blood sugar increased)" was unknown.The outcome for the event "plunger problem each time(device component issue)" was unknown.The outcome for the event "plunger problem each time, the required insulin dose is not been delivered(inaccurate delivery by device)" was unknown.References included: reference type: e2b company number.Reference id#: gb-novoprod-1188159.Reference notes: "this report is for a foreign device that is assessed as "similar" to us marketed novopen echo.".

Event Description

Case description: investigation results: name: novopen 6 blue, batch number: mvg8g82.A visual examination of the returned product was performed.The cartridge holder was damaged in its connection to the mechanical part of the pen.It is not possible to attach the cartridge holder correctly and the device cannot function with a needle and a cartridge attached.The dose accuracy might be affected.The fault was caused by accidental damage during use of the device.The number of complaints on the batch was evaluated and, when applicable, relevant actions were taken.The electronic register was checked.No remarks.A visual examination of the returned product was performed.It was not possible to perform a dose accuracy test due to the broken cartridge holder.Confirmed, during development of the fault on the cartridge holder starting with a crack and to the state that the cartridge holder was in during our examination, it could not be ruled out that the dosage accuracy was affected at a time during use.If the patient did not observe that the cartridge holder was damaged there was a risk that he/she would not receive the intended dose and experienced hyperglycaemia.It was not possible to investigate the returned sample comprehensively.Name: novopen, batch number :unknown.No investigation was possible, because neither sample nor batch number was available.Since last submission, the case has been updated with following information: investigation results added.Annex b, c, d and g codes updated.Relevant fields updated in eu/ca tab.Narrative updated accordingly.References included: reference type: e2b company number.Reference id#: gb-novoprod-1188159.Reference notes: final manufacturer's comment: 02-may-2024: the suspected device novopen 6 has been returned to novonordisk and was investigated.It was identified that the cartridge holder was damaged which was caused by accidental damage during the use of the suspect.However, it was not possible to investigate the returned sample comprehensively.It is not possible to perform a dose accuracy test due to the broken cartridge holder.If the patient does not observe that the cartridge holder is damaged there is a risk that he/she will not receive the intended dose and experience hyperglycaemia.Final manufacturer's comment: on 02-may-2024: the suspected device novopen has not been returned to novo nordisk for evaluation.The specific name of the device is unknown.Batch number of the device unavailable despite repeated efforts to find the same.No batch trend analysis or reference sample analysis performed.No other confounding factors identified.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.This report is for a foreign device that is assessed as "similar" to us marketed novopen echo.H3 continued: evaluation summary name: novopen 6 blue, batch number: mvg8g82.A visual examination of the returned product was performed.The cartridge holder was damaged in its connection to the mechanical part of the pen.It is not possible to attach the cartridge holder correctly and the device cannot function with a needle and a cartridge attached.The dose accuracy might be affected.The fault was caused by accidental damage during use of the device.The number of complaints on the batch was evaluated and, when applicable, relevant actions were taken.The electronic register was checked.No remarks.A visual examination of the returned product was performed.It was not possible to perform a dose accuracy test due to the broken cartridge holder.Confirmed during development of the fault on the cartridge holder starting with a crack and to the state that the cartridge holder was in during our examination, it could not be ruled out that the dosage accuracy was affected at a time during use.If the patient did not observe that the cartridge holder was damaged there was a risk that he/she would not receive the intended dose and experienced hyperglycaemia.It was not possible to investigate the returned sample comprehensively.

• Brand Name: NOVOPEN 6
• Type of Device: INSULIN DELIVERY DEVICE
• Manufacturer (Section D): NOVO NORDISK A/S; bagsvaerd,, ; DA
• Manufacturer (Section G): NOVO NORDISK A/S; krogshoejvej 55; bagsvaerd,, 2880 ; DA 2880
• Manufacturer Contact: p.o. box 846; plainsboro, NJ 08536 ; 8007276500
• MDR Report Key: 19010118
• MDR Text Key: 338981787
• Report Number: 9681821-2024-00051
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K123766N/A
• 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: 03/07/2024

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 Model Number: N/A
• Device Lot Number: MVG8G82
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2024
• Initial Date Manufacturer Received: 03/07/2024
• Initial Date FDA Received: 04/01/2024
• Supplement Dates Manufacturer Received: 04/25/2024
• Supplement Dates FDA Received: 05/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2022
• 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