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

Model Number N/A

Device Problems Excess Flow or Over-Infusion (1311); Wireless Communication Problem (3283)

Patient Problems Hypoglycemia (1912); Convulsion/Seizure (4406)

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas).Patient suffered from hypoglycaemia,epileptic seizure and convulsion [hypoglycaemic seizure].Pen was not working and the data had not been transferred [device wireless communication issue].Patient injected herself twice by mistake [extra dose administered].Case description: this serious spontaneous case from spain was reported by a pharmacist as "patient suffered from hypoglycaemia,epileptic seizure and convulsion(hypoglycemic seizure)" with an unspecified onset date, "pen was not working and the data had not been transferred(device wireless communication issue)" with an unspecified onset date, "patient injected herself twice by mistake(extra dose administered)" with an unspecified onset date, and concerned a 15 years old female patient who was treated with novopen echo plus (insulin delivery device) from unknown start date for "diabetes type 1", patient's height, weight and body mass index (bmi) were not reported.Current condition: diabetes type 1 (diagnosed at the age of 4).On an unknown date, patient had the problem of not being able to transfer the data from novopen echo plus to librelink, they first got "scanning error" and, after several attempts, they finally got "memory full.Due to the problem of not being able to transfer the data, the patient suffered from hypoglycaemia.Patient injected twice 10-15 minutes apart because the pen was not working and the data had not been transferred, so patient thought that patient had not yet injected.As a result, had a big drop in blood glucose (blood glucose), reaching 42 mg/dl on the meter.On an unknown date, the patient suffered "convulsions, like epileptic seizures.They did not go to the hospital, but the mother gave the patient two glasses of milk with some sugar, and gradually the blood glucose went up.Batch number of novopen echo plus: mvg6f01-1.Action taken to novopen echo plus was not reported.The outcome for the event "patient suffered from hypoglycaemia,epileptic seizure and convulsion(hypoglycemic seizure)" was not reported.The outcome for the event "pen was not working and the data had not been transferred(device wireless communication issue)" was not reported.The outcome for the event "patient injected herself twice by mistake(extra dose administered)" was not recovered.References included: reference type: e2b company.Number reference id#: (b)(4).

Event Description

Case description: since last submission the case has been updated with the following -expected fu date has been updated in eu/ca tab.

Event Description

Case description: investigation result - novopen echo plus - batch mvg6f01-1.A visual examination of the returned product was performed.The number of complaints on the batch was evaluated and, when applicable, relevant actions were taken.The electronic register was checked.No remarks.Visual examination and functional testing were performed.The mechanic pen mechanism was found to be function normal.During test the memory display mirrored the dialled units.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.During examination of the product, no irregularities related to the complaint were detected.Nfc statistics log shows: num of upload start: 179.Num of upload complete: 121.Num of upload failures - interrupted transfer: 56.Num of no app: 46.User has a decent rack record and seems to knows how to use the connectivity feature.The user has a success rate of (b)(4) procent.The memory in the novopen device revealed that transfer of data between the novopen and the application used was interrupted before the transfer was completed.Timestamp of last upload start (seconds) 16191787 seconds.Timestamp of last successful upload 16191787 seconds since activation.The last attempt the user used the pen was in contact with the nfc spot for 0 seconds the user did not use the connectivity feature for 0 amount of days.The statistics log shows: fw version 01.08.00 eod mismatches = 4.Eod switch failure = 0.['total resets: 5', 'reset bod: 5'] the resets is likely for the patients complaint, as resets will have a major impact on the dose log, thus the connectivity feature as every dose prior to the event will become invalidated.The eod error should not affect the connectivity feature of the pen dose log shows: total injected doses in doselog: (b)(4).Total invalid doses in doselog: (b)(4).About 74% of the doses in the doselog are invalid which was like why the customer was complaining about connectivity issues.The user did not managed to upload 2 doses from pen to app.The pen was clearly faulty, as seen with the resets which likely caused the 74% invalidated doses in the dose log.In the pen.From the user description there shouldnt be any issues as the logs should be in the app.Besides the reset, the connectivity feature are working.But heavily impacted by the reset.The display shows "error" due to an unexpected reset of the pen memory function.This means that the injected dose was not visible in the display.When trying to set new dose the error message disappears.Though the error message may be reoccurring.Furthermore, the current and all previous registered doses are not available any longer.As it was not possible to transfer the data of the registered doses prior to the reset, the data was also missing in the recorded dose log displayed in the app.However, the issue has no impact on the mechanical function of the pen and therefore, no impact on dosage accuracy.The fault was due to an error at novo nordisk.The electronic register was checked.In the log was detected: mcu reset due to power on and mcu reset due to brown out.The device was disassembled to examine internal parts and a microscopic examination was performed.No foreign matter was observed inside the dose selector module.Confirmed the display shows "error" due to an unexpected reset of the pen memory function.This means that the injected dose was not visible in the display.When trying to set new dose the error message disappears.Though the error message may be reoccurring.Furthermore, the current and all previous registered doses are not available any longer.As it was not possible to transfer the data of the registered doses prior to the reset, the data was also missing in the recorded dose log displayed in the app.However, the issue has no impact on the mechanical function of the pen and therefore, no impact on dosage accuracy.The fault was due to an error at novo nordisk.Since last submission, the case has been updated with the following: -investigation results updated.-imdrf codes updated.-narrative has been updated accordingly.Final manufacturer's comment: 16-jan-2024: the suspected device novopen echo plus has been returned to novo nordisk for evaluation.Upon preliminary examination, device was functioning normal.The device was tested with a random cartridge and a novo nordisk needle was mounted.The results were found to comply with specifications.The memory in the novopen device revealed that transfer of data between the novopen and the application used was interrupted before the transfer was completed.Since the injected dose is not visible, patient may administer again, thinking the dose not administered.This can lead to extra dose administered and subsequent hypoglycaemia and its complication.The observed problem was caused by unintended use of the device.H3 continued: evaluation summary novopen echo plus - batch mvg6f01-1.A visual examination of the returned product was performed.The number of complaints on the batch was evaluated and, when applicable, relevant actions were taken.The electronic register was checked.No remarks.Visual examination and functional testing were performed.The mechanic pen mechanism was found to be function normal.During test the memory display mirrored the dialled units.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.During examination of the product, no irregularities related to the complaint were detected.Nfc statistics log shows: num of upload start: 179.Num of upload complete: 121.Num of upload failures - interrupted transfer: 56.Num of no app: 46.User has a decent rack record and seems to knows how to use the connectivity feature.The user has a success rate of (b)(4) procent.The memory in the novopen device revealed that transfer of data between the novopen and the application used was interrupted before the transfer was completed.Timestamp of last upload start (seconds) 16191787 seconds timestamp of last successful upload 16191787 seconds since activation the last attempt the user used the pen was in contact with the nfc spot for 0 seconds the user did not use the connectivity feature for 0 amount of days the statistics log shows: fw version 01.08.00 eod mismatches = 4.Eod switch failure = 0.['total resets: (b)(4)].The resets was likely for the patients complaint, as resets will have a major impact on the dose log, thus the connectivity feature as every dose prior to the event will become invalidated the eod error should not affect the connectivity feature of the pen.

• 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: 18038900
• MDR Text Key: 326966317
• Report Number: 9681821-2023-00145
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K123766
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date: 10/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2023
• Device Model Number: N/A
• Device Lot Number: MVG6F01-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2022
• 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): Other
• Patient Age: 15 YR
• Patient Sex: Female