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

Model Number N/A

Device Problems Defective Device (2588); Mechanical Jam (2983)

Patient Problem Hyperglycemia (1905)

Event Date 06/01/2021

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas) blood glucose values suddenly started to increase [blood glucose increased] piston gets jammed [device mechanical issue] pen does not function properly [device malfunction] this serious spontaneous case from finland was reported by a nurse as "blood glucose values suddenly started to increase(blood sugar increased)" beginning on (b)(6) 2021, "piston gets jammed(device mechanical jam)" with an unspecified onset date, "pen does not function properly(device malfunction)" with an unspecified onset date, and concerned a elderly patient (age not reported) who was treated with novopen echo (insulin delivery device) from (b)(6) 2020 for "type 1 diabetes mellitus".The patient's height, weight and body mass index was not reported.Dosage regimens: novopen echo: ??-sep-2020 to ??-jun-2021; current condition: type 1 diabetes (duration not reported).Concomitant products included - insulin.The pen has been taken into use in (b)(6) 2020.Since an unspecified date in (b)(6) 2021, the patient's blood glucose values had suddenly started to increase.The insulin cartridges had been changed and blood glucose values decreased for a while, but one day before (from the day of reporting) the value was again 30 mmol/l.On the date of reporting, it was noticed that the pen did not function properly and the piston got jammed.The pen was changed to a new one.Blood glucose increased was reported as recovered.Batch numbers: novopen echo: jvgt681-1.Action taken to novopen echo was reported as no change.On (b)(6) 2021 the outcome for the event "blood glucose values suddenly started to increase(blood sugar increased)" was recovered.The outcome for the event "piston gets jammed(device mechanical jam)" was not reported.The outcome for the event "pen does not function properly(device malfunction)" was not reported.Preliminary manufacturer's comment: (b)(6) 2021: the suspected device (novopen echo) has not been returned to novo nordisk for evaluation.No conclusion is reached.Also relevant information on operator of the device, improper use or storage, training on product usage by health care professional, needle re-use and injection technique are unavailable for complete assessment.Elderly age of the patient (over 80 years) is a significant risk factor for hyperglycaemia.

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas).Blood glucose values suddenly started to increase(elevation of blood glucose levels) [blood glucose increased] piston gets jammed [device mechanical issue] pen does not function properly [device malfunction] case description: this serious spontaneous case from finland was reported by a nurse as "blood glucose values suddenly started to increase(elevation of blood glucose levels)(blood sugar increased)" beginning on (b)(6) 2021, "piston gets jammed (device mechanical jam)" with an unspecified onset date, "pen does not function properly(device malfunction)" with an unspecified onset date, and concerned a elderly patient who was treated with novopen echo (insulin delivery device) from (b)(6) 2020 for "type 1 diabetes mellitus", , novorapid penfill (insulin aspart) solution for injection, 100 iu/ml, (dose, frequency & route used- unk, unknown) from unknown start date and ongoing for "drug used for unknown indication", the needle has been changed for each injection and the pen has been stored without needle in between of injections.The patient has used the dialling clicks to estimate the dose of the insulin.Batch number of novorapid penfill has been requested.Action taken to novorapid penfill was reported as no change.On (b)(6) 2021 the outcome for the event "blood glucose values suddenly started to increase(elevation of blood glucose levels)(blood sugar increased)" was recovered.Investigation results: novopen echo® blue - batch jvgt681-4 a visual examination of the returned product was performed.The batch documentation was reviewed.No abnormalities relating to the observed problem were found.The batch documentation was reviewed and found to be normal.The electronic register was checked.Several mitigation codes were present which indicate use of a broken or blocked needle 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 product was found to be normal.The function of the piston rod was found to be normal.Confirmed the memory data in the device revealed that an attempted injection did not turn out to be successful and that this was caused by no flow in the delivery system (e.G.The use of a clogged needle on the pen during use).This also made the memory display warn the user by showing two lines (- -) after the attempted injection.In the injection to follow the attempted but faulty injection the pen will function as normal again, if a new injection needle was mounted on the pen immediately before the injection.The observed problem was caused by unintended use of the device.Novorapid® penfill® 100 u/ml 3 ml - batch unknown no investigation was possible, because neither sample nor batch number was available.If possible, please forward the reported product(s) for further investigations.Since last submission, the case has been updated with the following: suspect drug "novorapid® penfill" added concomitant insulin deleted for event "blood glucose values suddenly started to increase" verbatim updated and treatment received added.Reporter comment added.Narrative updated accordingly.Reporter comment: there was nothing abnormal regarding the force needed for pressing of the push button.The insulin cartridge had been changed about a week before the patient had noticed the problem regarding the pen.First thought had been that the increased blood glucose values would be caused by for example warmed insulin.But the change of the cartridge has not helped.There has not been anything special in the daily life that might have had an effect to the blood glucose values.According to the patient the blood glucose values have started to decrease after the change of the pen and there has not been any mentions of hi anymore.Final manufacturer's comment: 12-aug-2021: the suspected device novopen echo has been returned to novo nordisk for evaluation.Upon investigation, device was found to function normally when tested with new needle.It was working in accordance to specification.However, 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.Elderly age of the patient (over 80 years) is a significant risk factor for hyperglycaemia.Reported events are listed.This single case report is not considered to change the current knowledge of the safety profile of novorapid penfill.H3 continued: evaluation summary: novopen echo® blue - batch jvgt681-4 a visual examination of the returned product was performed.The batch documentation was reviewed.No abnormalities relating to the observed problem were found.The batch documentation was reviewed and found to be normal.The electronic register was checked.Several mitigation codes were present which indicate use of a broken or blocked needle 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 product was found to be normal.The function of the piston rod was found to be normal.Confirmed the memory data in the device revealed that an attempted injection did not turn out to be successful and that this was caused by no flow in the delivery system (e.G.The use of a clogged needle on the pen during use).This also made the memory display warn the user by showing two lines (- -) after the attempted injection.In the injection to follow the attempted but faulty injection the pen will function as normal again, if a new injection needle was mounted on the pen immediately before the injection.The observed problem was caused by unintended use of the device.

Event Description

Case description: investigation results: novopen echo blue - batch jvgt681-4.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 product was found to be normal.The function of the piston rod was found to be normal.The batch documentation was reviewed and found to be normal.The electronic register was checked.Visual examination and functional testing were performed.Several mitigation codes were present which indicate use of a broken or blocked needle.The memory data in the device revealed that an attempted injection did not turn out to be successful and that this was caused by no flow in the delivery system (e.G.The use of a clogged needle on the pen during use).This also made the memory display warn the user by showing two lines (- -) after the attempted injection.In the injection to follow the attempted but faulty injection, the pen would function as normal again, if a new injection needle mounted on the pen immediately before the injection.The observed problem was caused by unintended use of the device.Final manufacturer's comment: 12-aug-2021: the suspected device novopen echo has been returned to novo nordisk for evaluation.Upon investigation, device was found to function normally when tested with new needle.It was working in accordance to specification.However, 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.Elderly age of the patient (over 80 years) is a significant risk factor for hyperglycaemia.H3 continued: evaluation summary: investigation results: novopen echo blue - batch jvgt681-4: 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 product was found to be normal.The function of the piston rod was found to be normal.The batch documentation was reviewed and found to be normal.The electronic register was checked.Visual examination and functional testing were performed.Several mitigation codes were present which indicate use of a broken or blocked needle.The memory data in the device revealed that an attempted injection did not turn out to be successful and that this was caused by no flow in the delivery system (e.G.The use of a clogged needle on the pen during use).This also made the memory display warn the user by showing two lines (- -) after the attempted injection.In the injection to follow the attempted but faulty injection, the pen would function as normal again, if a new injection needle mounted on the pen immediately before the injection.The observed problem was caused by unintended use of the device.

• Brand Name: NOVOPEN ECHO
• Type of Device: INSULIN DELIVERY DEVICE
• Manufacturer (Section D): NOVO NORDISK A/S, MEDICAL SYSTEMS; hilleroed, ; DA
• MDR Report Key: 12141505
• MDR Text Key: 260706098
• Report Number: 9681821-2021-00032
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• PMA/PMN Number: K123766
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/22/2021

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: No Information
• Device Expiration Date: 05/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 185458
• Device Lot Number: JVGT681-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2021
• Initial Date Manufacturer Received: 06/22/2021
• Initial Date FDA Received: 07/09/2021
• Supplement Dates Manufacturer Received: 08/05/2021; 09/16/2021
• Supplement Dates FDA Received: 08/20/2021; 09/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: INSULIN (INSULIN) SOLUTION FOR INJECTION; INSULIN (INSULIN) SOLUTION FOR INJECTION
• Patient Outcome(s): Other