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

Model Number N/A

Device Problems Defective Component (2292); Failure to Deliver (2338); Improper Flow or Infusion (2954); Mechanical Jam (2983)

Patient Problem Hyperglycemia (1905)

Event Type  Injury  

Event Description

Hyperglycaemia [hyperglycaemia].Novopen echo is locked and hard [device mechanical issue].The pen is not delivering insulin [device failure].This pen does not dispense 0.5 in 0.5 iu doses [device delivery system issue].The button is too hard and has to force to press it [device malfunction].Case description: this serious spontaneous case from (b)(6)was reported by a consumer as "hyperglycaemia(hyperglycaemia)" with an unspecified onset date, "novopen echo is locked and hard(device mechanical jam)" with an unspecified onset date, "the pen is not delivering insulin(device failure)" with an unspecified onset date, "this pen does not dispense 0.5 in 0.5 iu doses(device delivery system issue)" with an unspecified onset date, "the button is too hard and has to force to press it(device component malfunction)" with an unspecified onset date, and concerned a female patient (born in (b)(6)) who was treated with novopen echo (insulin delivery device) from unknown start date for "device therapy", , fiasp penfill (insulin aspart) solution for injection, 100 iu/ml (dose, frequency & route used- unk, unknown, regimen#2 unk, unknown, regimen#3 unk, unknown (b)(6) 2021 to unk) from (b)(6) 2021 for "drug use for unknown indication".Patient's height, weight and body mass index was not reported.Dosage regimens: novopen echo: fiasp penfill: (b)(6) 2021 to not reported, not reported to not reported, (b)(6) 2021 to not reported; medical history was not provided.On (b)(6) 2021 patient purchased novopen echo.The patient reported that on the evening of (b)(6) 2021 she took fiasp insulin with novopen echo normally after dinner.She explained that the fiasp penfill had been opened for 1 week.When she slept, her blood glucose was still high, but she believed it would go down and the insulin effect would take place.However, during the night she woke up twice feeling unwell and with her glucose showing at hi (high), which she claims was too high.Both times, she applied the insulin again using the same pen and always changing the needles (not specified the brand) and finally going back to sleep.At 5 am, she woke up with her blood glucose still on hi.Then, she verified that the pen was not dispensing insulin.She explained that there were no blisters in the ampoule and no problem with the needle.She tested the pen several times and found that in fact the insulin was not coming out.Because of this, she needed to look for an immediate solution, where around 5 am on (b)(6) 2021, she adapted the fiasp penfill in another pen (lilly's luxura hd pen).This action resolved the situation momentarily, because there was no guarantee of dose accuracy and due to the time, she could not go out to buy another insulin.Finally, as soon as possible, the patient bought a fiaso flextouch to follow the treatment, but she points out that this makes her treatment difficult, because this pen does not dispense 0.5 in 0.5 iu doses.On an unknown date, patient clarified that novopen echo was locked and hard.The flow test was performed during attendance and in the second attempt the pen has delivered insulin and the dosage selector come out to zero position.Despite the test result, the patient informed that patient did not feel safe to use the product, since patient had hyperglycemia.Patient also pointed out that the button was too hard and that patient had to force to press it.Batch numbers: novopen echo: jvgv956.Fiasp penfill was requested.Action taken to novopen echo was reported as product discontinued due to ae.Action taken to fiasp penfill was reported as product discontinued due to ae.The outcome for the event "hyperglycaemia(hyperglycaemia)" was unknown.The outcome for the event "novopen echo is locked and hard(device mechanical jam)" was unknown.The outcome for the event "the pen is not delivering insulin(device failure)" was unknown.The outcome for the event "this pen does not dispense 0.5 in 0.5 iu doses(device delivery system issue)" was not reported.The outcome for the event "the button is too hard and has to force to press it(device component malfunction)" was not reported.In order to protect the safety of patient it will, in rare cases, be required to disassemble the medical device immediately in a way where it is not subsequently possible to reassemble it (e.G.Destructive testing or altering of the medical device).The disassembled medical device will be stored with the same retention period as other complaint samples.Reporter comment: the patient bought a fiaso flextouch to follow the treatment, but she points out that this makes her treatment difficult - patient started using this novopen echo on (b)(6) 2020.

Event Description

Case description: investigation result: name: novopen echo, batch number: jvgv956.A visual examination of the returned product was performed.Foreign dry matter observed on internal or external pen parts e.G., dust, dirt, or dried stains after a liquid.The observed problem is not related to any novo nordisk processes and it is a result of accidental damage during use of the device.The electronic register was checked.No more marks.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 force required to depress the push-button was measured.The results were in the hige end but within the specification limit.The results were found to comply with specifications.Microscopic examination performed.Foreign matter was observed inside the pen mechanism causing the sound from the pen to differ from normal.The observed problem is not related to any novo nordisk processes and it is a result of accidental damage during use of the device.Name: fiasp penfill batch number: unknown no investigation was possible, because neither sample nor batch number was available.Since last submission, following has been updated in the case: -investigation updated for suspect products.-device available for evaluation updated.-eu/ca tab - further information updated, final report ticked.-device addendum updated (b,c,d,g codes and device narrative).-narrative updated accordingly.Final manufacturer's comment: (b)(6) 2022: the suspected device novopen echo has been returned to novo nordisk for investigation.The device was found to function as per specification, except foreign matter observed inside he pen mechanism causing the sound from the pen to differ from normal.The observed problem is not related to any novo nordisk processes and it is a result of accidental damage during use of the device.This fault has no impact on patient's health or treatment.With limited information on handling of device, it is not possible to elucidate a clear root cause in relation to functionality of novopen echo.Elderly age of the patient is a confounding factor for the development of hyperglycaemia.H3 continued: evaluation summary: name: novopen echo, batch number: jvgv956.A visual examination of the returned product was performed.Foreign dry matter observed on internal or external pen parts e.G., dust, dirt, or dried stains after a liquid.The observed problem is not related to any novo nordisk processes and it is a result of accidental damage during use of the device.The electronic register was checked.No more marks.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 force required to depress the push-button was measured.The results were in the hige end but within the specification limit.The results were found to comply with specifications.Microscopic examination performed.Foreign matter was observed inside the pen mechanism causing the sound from the pen to differ from normal.The observed problem is not related to any novo nordisk processes and it is a result of accidental damage during 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
• 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: 12959177
• MDR Text Key: 287823721
• Report Number: 9681821-2021-00087
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• Reporter Country Code: BR
• 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
• Report Date: 11/17/2021

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: Lay User/Patient
• Device Expiration Date: 08/25/2021
• Device Model Number: N/A
• Device Catalogue Number: 185459
• Device Lot Number: JVGV956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2021
• Initial Date Manufacturer Received: 11/17/2021
• Initial Date FDA Received: 12/08/2021
• Supplement Dates Manufacturer Received: 01/25/2022
• Supplement Dates FDA Received: 02/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2019
• 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 Sex: Female