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

Model Number N/A

Device Problems Inaccurate Delivery (2339); Device Displays Incorrect Message (2591); Mechanical Jam (2983)

Patient Problem Diabetic Ketoacidosis (2364)

Event Date 10/04/2023

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas).Ketoacidosis [ketoacidosis].Sometimes device delivers the correct dose, but sometimes not [device delivery system issue].The piston rod is not moving and no insulin is delivered [device mechanical issue] no insulin is delivered [device failure].Screen still shows the previous injection and not the one just performed [device information output issue] case description: this serious spontaneous case from estonia was reported by a consumer as "ketoacidosis(ketoacidosis)" beginning on (b)(6) 2023, "sometimes device delivers the correct dose, but sometimes not(device delivery system improper flow)" beginning on (b)(6) 2023, "the piston rod is not moving and no insulin is delivered(device mechanical jam)" beginning on 04-oct-2023, "no insulin is delivered(device failure)" beginning on (b)(6) 2023, "screen still shows the previous injection and not the one just performed(device image display issue)" beginning on (b)(6) 2023, and concerned a 69 years old female patient 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 (b)(6) 2023 patient was complaining that the device was not working properly.It was also reported that sometimes it delivers the dose correctly, but sometimes not, if they push the dose buttom, the pistin rod was not moving and no insulin was delivered, although they can hear and feel the click in the end of injection due to which the patient experienced ketoacidosis.It was also reported that the screen still shows the previous injection, not the one just performed.It was reported that as devie was not working properly and no insulin was actually injected, patient suffered ketoacidosis and was therefore hospitalised.Batch number of novopen echo plus was requested.The outcome for the event "ketoacidosis(ketoacidosis)" was not recovered.The outcome for the event "sometimes device delivers the correct dose, but sometimes not(device delivery system improper flow)" was not reported.The outcome for the event "the piston rod is not moving and no insulin is delivered(device mechanical jam)" was not reported.The outcome for the event "no insulin is delivered(device failure)" was not reported.The outcome for the event "screen still shows the previous injection and not the one just performed(device image display issue)" was not reported.References included: reference type: e2b company number.Reference id#: ee-novoprod-1124477.Reference notes:.

Event Description

Case description: batch number of novopen echo plus mvg8m31.Since last submission the case has been updated with the following: - the product tab updated with batch number and related tabs.-relevant fields updated in eu/ca and device addendum - narrative was updated accordingly.References included: reference type: e2b company number reference id#: (b)(4) reference notes: reference type: (b)(4) reference id#: (b)(4) reference notes: medwatch 3500a mfr.Report number.

Event Description

Case description: investigation result: name: novopen echo plus, batch number: mvg8m31.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 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 product was found to be normal.The results were found to comply with specifications.Use a new unused needle for each injection.The needle should be mounted immediately before the injection.Always remove the used needle immediately after each injection and store the device without a needle attached otherwise, temperature fluctuations may cause leakage through the needle, resulting in a space between the rubber piston in the cartridge and the piston rod in the device this will make the piston rod to slip during the dosing process, furthermore, clogging of the needle may occur.If the needle is clogged or the needle is not correctly mounted on to the cartridge no medication will come out of the device.During examination of the product, no irregularities related to the complaint were detected.References included: reference type: e2b company number.Reference id#: ee-novoprod-1124477.Reference notes: reference type: mw 3500a mfr.Rpt.# reference id#: (b)(4).Reference notes: medwatch 3500a mfr.Report number.Final manufacturer's comment: 06-dec-2023: the suspected device novopen echo plus has been returned to novo nordisk for evaluation.Upon investigation, device was found to be functioning normally, as per the specifications.During examination of the product, no irregularities related to the complaint were detected.No abnormalities relating to the observed problem were found in the reference sample analysis.The batch documentation has been reviewed and found to be normal.Since no faults were found on the returned device novopen echo plus and only very limited information regarding the patients handling of the suspected device is reported in the case, it is not possible to elucidate a clear root cause for the experienced adverse events.H3 continued: evaluation summary name: novopen echo plus, batch number: mvg8m31.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 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 product was found to be normal.The results were found to comply with specifications.Use a new unused needle for each injection.The needle should be mounted immediately before the injection.Always remove the used needle immediately after each injection and store the device without a needle attached otherwise, temperature fluctuations may cause leakage through the needle, resulting in a space between the rubber piston in the cartridge and the piston rod in the device this will make the piston rod to slip during the dosing process, furthermore, clogging of the needle may occur.If the needle is clogged or the needle is not correctly mounted on to the cartridge no medication will come out of the device.During examination of the product, no irregularities related to the complaint were detected.

• 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: 18010872
• MDR Text Key: 326608481
• Report Number: 9681821-2023-00143
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: EN
• 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: 10/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: N/A
• Device Lot Number: MVG8M31
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 12/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2022
• 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; Hospitalization
• Patient Age: 69 YR
• Patient Sex: Female