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

Model Number N/A

Device Problems Inaccurate Delivery (2339); Defective Device (2588); Device Displays Incorrect Message (2591)

Patient Problem Hypoglycemia (1912)

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas).Extreme hypo as the blood glucose 1.5.[hypoglycaemia].The pen may be faulty.[device defective].Case description: this serious spontaneous case from the united kingdom was reported by a nurse as "extreme hypo as the blood glucose 1.5.(hypoglycaemia)" with an unspecified onset date, "the pen may be faulty.(device defective)" with an unspecified onset date, and concerned a patient (age and gender not reported) who was treated with novopen echo plus (insulin delivery device) from unknown start date for "device therapy", patient's height, weight and body mass index(bmi) were not reported.Medical history was not provided.On an unknown date, patient experienced extreme hypoglycemia as the blood glucose(blood glucose) 1.5(units not reported).The reporter stated that the mother have gluco app synched.Prior to having the insulin, the app was showing 2 large doses one at 5 am and one at 7 am meanwhile the patient was asleep on that time, so no medication was given.It was suspected that the pen may be faulty as the pen is new to them only 3 months old.The patient was given a new pen.Batch numbers: novopen echo plus: requested.The outcome for the event "extreme hypo as the blood glucose 1.5.(hypoglycaemia)" was unknown.The outcome for the event "the pen may be faulty.(device defective)" was unknown.

Event Description

Case description: this serious spontaneous case from the united kingdom was reported by a nurse as "extreme hypo as the blood glucose 1.5.(hypoglycaemia)" with an unspecified onset date, "the pen may be faulty.(device defective)" with an unspecified onset date, and concerned a patient who was treated with novopen echo plus (insulin delivery device) from unknown start date for "device therapy", batch numbers: novopen echo plus: lvg2y88.Since last submission, the case has been updated with the following: novopen echo plus batch number updated.Sample available for evaluation marked as"returned to manufacturer".Current location updated in eu/ca tab.Narrative updated accordingly.

Event Description

Since last submission, the case has been updated with the following: the final report date has been updated to 26-jul-2023 in eu/ca device tab since investigation results and imdrf codes of novopen echo plus are still under investigation.

Event Description

Case description: name:novopen echo plus batch number: lvg2y88.A visual examination of the returned product was performed.The electronic register was checked.No remarks.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 including the piston rod was found to be normal.Due to the design of the pen the piston rod will only move correctly when a cartridge is mounted in the pen.When the piston is fully retracted it can only be released when mounting the cartridge holder with a cartridge inside.With no cartridge mounted the locking function of the piston is not activated and the movement of the dosage button is not transferred to the piston rod.During examination of the product, no irregularities related to the complaint were detected.The electronic register was checked.No remarks.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 including the piston rodwas found to be normal.Due to the design of the pen the piston rod will only move correctly when a cartridge is mounted in the pen.When the piston is fully retracted it can only be released when mounting the cartridge holder with a cartridge inside.With no cartridge mounted the locking function of the piston is not activated and the movement of the dosage button is not transferred to the piston rod.The tests shows a normal product.The logs do not show any issue related to the customer complaint.The nightly doses of 30 units are in the extracted dose logs.We can then exclude a connectivity issue or glooko app issue.It may have been the patient installing a half-used penfill, and then dosing large doses in order to move the piston rod forward to the plunger.The fact that there are primings in the sequence as well as the timing of the doses contradicts this theory.We can not confirm any issues with the registration of those dose logs.The other issues in the logs do not relate to the customer complaint and the adverse event.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 "error" 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 is mounted on the pen immediately before the injection.The observed problem is caused by unintended use of the device.The memory display shows "error" instead of showing the last injected dose size.The fault has no impact on the mechanical functions of the pen and is caused by an error in novo nordisk a/s.Since last submission, the case has been updated with the following: inv results were updated.-imdrf b, c, d, g codes updated.-narrative updated accoridngly final manufacturer's comment: 22-aug-2023: the suspected device novopen echo plus has been returned to novo nordisk for evaluation.The device was found to work as intended when tested with new cartridge and 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 "error" after the attempted injection.The observed problem is caused by unintended use of the device.The issue has no impact on the mechanical function of the pen and therefore, no impact on dosage accuracy.Medical consequences: the fault has no impact on the patient's treatment or health.H3 continued: evaluation summary name:novopen echo plus batch number:lvg2y88 a visual examination of the returned product was performed.The electronic register was checked.No remarks.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 including the piston rod was found to be normal.During examination of the product, no irregularities related to the complaint were detected.The product including the piston rod was found to be normal.The tests shows a normal product.The logs do not show any issue related to the customer complaint.We can not confirm any issues with the registration of those dose logs.The other issues in the logs do not relate to the customer complaint and the adverse event."statistic log analyzed from d station.General : fw: 01.08.00.Pen logs read after 175 day(s) after user activation.1012 injections.Error(s)!: it explains error in the display marked as error in the dose log: the logs show 4 negative doses.It indicates a blocked needle scenario.The logs show 9 timeout doses.It can be due to handling, a fw bug or eod switch instability (72 eodmismatches).The fw bug is the most likely scenario.Warning only: nothing in the display and no error in the dose log: the logs show (72 eodmismatches) and (6 eoderrorcorrections).It can indicate a scenario where the eod is not reliably detected.The logs show (2 gcerrorcorrections).It can indicate foreign matter in the gc cylinder." the observed problem is caused by unintended use of the device.The memory display shows "error" instead of showing the last injected dose size.The fault has no impact on the mechanical functions of the pen and is caused by an error in novo nordisk a/s.Non codeable cause investigation - investigation findings: fda 4253 (problems that occurred due to an obstruction or blockage).

• Brand Name: NOVOPEN ECHO PLUS
• 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: 17032282
• MDR Text Key: 316294983
• Report Number: 9681821-2023-00079
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K123766
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 02/18/2023
• Device Model Number: N/A
• Device Lot Number: LVG2Y88
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2021
• 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): Other