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

Catalog Number 185458

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Diabetic Ketoacidosis (2364)

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas) diabetic patient experienced ketoacidosis [diabetic ketoacidosis] memory display sometimes shows error and the time display shows permanently same time [device information output issue] case description: this serious spontaneous case from germany was reported by a consumer as "diabetic patient experienced ketoacidosis(diabetic ketoacidosis)" with an unspecified onset date, "memory display sometimes shows error and the time display shows permanently same time(device image display error)" with an unspecified onset date, and concerned a 14 years old female patient who was treated with novopen echo plus (insulin delivery device) from unknown start date for "device therapy", , tresiba penfill (insulin degludec) (dose, frequency & route used-unk) from unknown start date for "product used for unknown indication", fiasp (insulin aspart) (dose, frequency & route used-unk) from unknown start date for "product used for unknown indication" patient heigth, weight and bmi not reported.Dosage regimens: novopen echo plus: tresiba penfill: fiasp: current condition: type 1 diabetes mellitus (duration not reported) on an unknown date patient was hospitalized (duration not reported) due to diabetic ketoacidosis.The memory display of the pen sometimes shows error and the time display shows same time permanently as '99:59:59'.Batch number of novopen echo plus: mvg8g67-2 batch numbers of tresiba penfill and fiasp were requested action taken to tresiba penfill was not reported.Action taken to fiasp was not reported.The outcome for the event "diabetic patient experienced ketoacidosis(diabetic ketoacidosis)" was not reported.The outcome for the event "memory display sometimes shows error and the time display shows permanently same time(device image display error)" was not reported.

Event Description

Case description: since the last submission the case has been updated with the following: -device available for evaluation and returned to manufacturer on fields were updated.References included: reference type: e2b company number; reference id#: (b)(4).Reference type: mw 3500a mfr.Rpt.#; reference id#: (b)(4).Reference notes: medwatch 3500a mfr.Report number.

Event Description

Case description: on (b)(6) 2023, the final report date has been updated since investigation results and imdrf codes of novopen echo plus are still under investigation.Since the last submission the case has been updated with the following: final report date was updated in eu/ca tab as investigation results of novopen echo plus are still ongoing.

Event Description

Name: novopen echo plus, batch number: mvg8g67-2.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.Memory display time was showing 99:59:59' the dose accuracy was measured by weighing using a random cartridge.The results were found to comply with specifications.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.During test the time changes, and the pen was tjecked 10 houers later and the memory display was showing 10:11:08 and was counting 10:11:09, 10:11:10 10:11:11 etc.A visual examination of the returned product was performed.The electronic register was checked.The display has been checked to work properly.All mechanical functions were found to be normal.1 time out doses and 2 eod mismatched were observed in statistics log.This explains the customer complaint.Confirmed.The electronic display showed "error" after the dose button was fully depressed.This was a normal function of the pen to warn the user of non-recommended user behavior.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 was caused by unintended use of the device.Name tresiba penfill batch number: unknown.No investigation was possible, because neither sample nor batch number was available.Name:fiasp penfill batch number :unknown.No investigation was possible, because neither sample nor batch number was available.References included: reference type: e2b company number.Reference id#: (b)(6).Reference notes: reference type: mw 3500a mfr.Rpt.#.Reference id#: 9681821-2023-00097.Reference notes: medwatch 3500a mfr.Report number.Final manufacturer's comment: 22-sep-2023: the suspected device novopen echo plus has been returned to novo nordisk for evaluation.Upon preliminary examination, device was found to be functioning as per the specification.The display has been checked to work properly.All mechanical functions were found to be normal.However, when the memory data is checked, it was found that one time out doses and two eod mismatched were observed in statistics log.This explains the customer complaint.The electronic display showed "error" after the dose button was fully depressed.The error was caused by unintended use of the device.H3 continued: evaluation summary name: novopen echo plus, batch number: mvg8g67-2.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.Memory display time was showing 99:59:59' the dose accuracy was measured by weighing using a random cartridge.The results were found to comply with specifications.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.During test the time changes, and the pen was tjecked 10 houers later and the memory display was showing 10:11:08 and was counting 10:11:09, 10:11:10 10:11:11 etc.A visual examination of the returned product was performed.The electronic register was checked.The display has been checked to work properly.All mechanical functions were found to be normal.1 time out doses and 2 eod mismatched were observed in statistics log.This explains the customer complaint.Confirmed.The electronic display showed "error" after the dose button was fully depressed.This was a normal function of the pen to warn the user of non-recommended user behavior.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 was caused by unintended use of the device.

• 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: 17396081
• MDR Text Key: 319767180
• Report Number: 9681821-2023-00097
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• Reporter Country Code: GM
• 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,Followup
• Report Date: 06/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 185458
• Device Lot Number: MVG8G67-2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 09/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2022
• 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
• Patient Age: 14 YR
• Patient Sex: Female