MAUDE Adverse Event Report: NOVO NORDISK A/S NOVOPEN 5; INSULIN DELIVERY DEVICE

Model Number N/A

Device Problems Defective Component (2292); No Flow (2991)

Patient Problem Hyperglycemia (1905)

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas) blood sugar was too high [blood glucose increased].No insulin was coming out of the pens [device failure].Piston rods no longer work in both pens [device malfunction].Case description: this serious spontaneous case from austria was reported by a consumer as "blood sugar was too high(blood glucose increased)" with an unspecified onset date, "no insulin was coming out of the pens(device failure)" with an unspecified onset date, "piston rods no longer work in both pens(device component malfunction)" with an unspecified onset date, and concerned a female patient who was treated with novopen 5 (insulin delivery device) from unknown start date for "diabetes mellitus", , novopen echo (insulin delivery device) from unknown start date for "diabetes mellitus", , tresiba penfill 100 u/ml (insulin degludec) solution for injection, 100 iu/ml (dose, frequency & route used unk, regimen # 2 unk (2x insulin),unknown) from unknown start date and ongoing for "diabetes mellitus", , novorapid penfill (insulin aspart) solution for injection, 100 iu/ml (dose, frequency & route used unk, regimen # 2 unk (2x insulin) unknown) from unknown start date and ongoing for "diabetes mellitus", patient's height, weight and body mass index was not reported current condition: diabetes mellitus (type and duration not reported), dementia.On an unknown date, patient using two pens (for about a year) with memory function (one for long-term insulin and one for short-term insulin) experienced high blood sugar and was hospitalized due to this event (details not specified).Reporter said that nurses were simply not injecting enough (they were following the doctor's instructions and not the functional insulin therapy).Later, 2x insulin was injected to correct it, but patient did not respond to the insulin at all and the blood sugar remained consistently high.It was noticed during another check that no insulin came out of the pen for short-term insulin.Also with the pen for the long-term insulin no insulin came.On an unknown date, it was reported that the piston rods no longer worked in both pens.Needles (not specified) are screwed on again before each injection and both the pens are defective.Now the patient was doing well, using replacement pens, but blood glucose was still elevated.Batch numbers: novopen 5: wvgt505 (non-valid), novopen echo: wvgt190 (non-valid), tresiba penfill 100 u/ml: unavailable, novorapid penfill: asku, unavailable.Action taken to novopen 5 was reported as product discontinued due to ae.Action taken to novopen echo was reported as product discontinued due to ae.Action taken to tresiba penfill 100 u/ml was not reported.Action taken to novorapid penfill was not reported.The outcome for the event "blood sugar was too high(blood glucose increased)" was not recovered.The outcome for the event "no insulin was coming out of the pens(device failure)" was not reported.The outcome for the event "piston rods no longer work in both pens(device component malfunction)" was not reported.No further information available.This report includes a foreign device (novopen 5) that is assessed as "similar" to us marketed novopen echo.

Event Description

Name: novopen 5, batch number: jvgt505.A visual examination of the returned product was performed.The electronic register was checked.Mitigation codes indicating that the user split the selected dose into two or more smaller doses which were delivered over a period of more than 15 minutes were present.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 function of the piston rod was found normal.The dose accuracy was measured by weighing using a random cartridge.The results were found to comply with specifications.The dose accuracy was measured by weighing using a random cartridge.The product was found to be normal.The results were found to comply with specifications.The electronic display showed two lines; -- after the dose button was fully depressed.This is a normal function of the pen in order to warn the user of non-recommended user behaviour.The user split the selected dose into two or more smaller doses which were delivered over a period of more than 15 minutes.The error is caused by unintended use of the device.Name: novopen echo, batch number: jvgt190.A visual examination of the returned product was performed.Foreign dry matter observed on internal or external pen parts e.G.Dust, dirt or dried stains after a liquid.The observed problem is not related to any novo nordisk processes.The observed fault is a result of accidental damage during use of the device.The electronic register was checked.Mitigation codes indicating foreign matter on electronic parts were present.The register revealed that the user split the selected dose into two or more smaller doses which were delivered over a period of more than 15 minutes.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.The observed problem was caused by interference from foreign matter entering the pen and is due to accidental handling during use.Confirm the electronic display showed two lines; - - after the dose button was fully depressed.This is a normal function of the pen in order to warn the user of non-recommended user behaviour.The user split the selected dose into two or more smaller doses which were delivered over a period of more than 15 minutes.The error is caused by unintended use of the device.Name: tresiba, batch number: unknown : no investigation was possible, because neither sample nor batch number was available.Name: novorapid, batch number: unknown : no investigation was possible, because neither sample nor batch number was available.Since last submission case updated with the following information: investigation results updated for all suspect products, imdrf codes available, narrative updated accordingly.Final manufacturer's comment: 20-dec-2021: upon investigating the suspected returned device (novopen 5, batch number jvgt505), there was no remark on the piston rod or pen (visual examination).The returned device was found to function normally.The memory data in the device has revealed that the memory display has shown two lines (- -) after an attempted injection during use.The observed problem is caused by the use of a clogged needle on the pen.The patient will not receive any insulin and could experience a hyperglycemic event.The fault is caused by incorrect handling during use of the device.20-dec-2021: upon investigating the suspected returned device (novopen echo, batch number jvgt190), foreign dry matter observed on internal or external pen parts e.G.Dust, dirt or dried stains after a liquid.The observed problem is not related to any novo nordisk processes.The observed fault is a result of accidental damage during use of the device.The returned device was found to function normally.The memory data in the device has revealed that the memory display has shown two lines (- -) after an attempted injection during use.The observed problem is caused by the use of a clogged needle on the pen.The patient will not receive any insulin and could experience a hyperglycemic event.The fault is caused by incorrect handling during use of the device."this report includes a foreign device (novopen 5) that is assessed as "similar" to us marketed novopen echo".

Event Description

Case description: batch numbers: novopen 5: jvgt505.Novopen echo: jvgt190.Tresiba penfill 100 u/ml and novorapid penfil were requested.Since last submission case updated with the following information: -batch numbers for novopen echo and novopen 5 were updated.-device available for evaluation were updated.-narrative updated accordingly.Preliminary manufacturer's comment: 26-oct-2021: the suspected device novopen echo, batch number jvgt190 has been returned to novo nordisk for evaluation.Investigation is ongoing.26-oct-2021: the suspected device novopen 5, batch number jvgt505 has been returned to novo nordisk for evaluation.Investigation is ongoing.Reporter comment: handling error cannot be ruled out.Also, the nurses often do not dare to correct if the blood sugar is too high.

• Brand Name: NOVOPEN 5
• Type of Device: INSULIN DELIVERY DEVICE
• Manufacturer (Section D): NOVO NORDISK A/S; bagsvaerd,, ; 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: 12647284
• MDR Text Key: 276907280
• Report Number: 9681821-2021-00064
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• Reporter Country Code: AU
• PMA/PMN Number: K123766
• 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,Followup
• Report Date: 10/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/13/2021
• Device Model Number: N/A
• Device Lot Number: JVGT505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2021
• Date Manufacturer Received: 12/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2019
• 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
• Patient Sex: Female