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

Model Number N/A

Device Problem Failure to Deliver (2338)

Patient Problem Diabetic Ketoacidosis (2364)

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas).High keytones level up to 4.2 [blood ketone body increased].Novopen echo was not delivering her long acting insulin (levemir) [device failure].Case description: this serious spontaneous case from (b)(6) was reported by a consumer as "high keytones level up to 4.2(blood ketone body increased)" with an unspecified onset date, "novopen echo was not delivering her long acting insulin (levemir)(device failure)" with an unspecified onset date, and concerned a female patient who was treated with novopen echo (insulin delivery device) from unknown start date for "type 1 diabetes mellitus", , levemir penfill (insulin detemir) solution for injection,.0024 mol/l, dose, frequency & route used- unk, unknown from unknown start date and ongoing for "type 1 diabetes mellitus", patient's height, weight and body mass index were not reported.Current condition: type 1 diabetes mellitus (duration not reported).Concomitant products included - novorapid penfill(insulin aspart) solution for injection, 100 iu/ml ongoing.On an unknown date, ketone levels were high up to 4.2 (units not reported).The novopen echo was not delivering her long acting insulin (levemir).After a certain time period readings returned to a more normal reading (details unknown).A new novopen echo was sent for use with the levemir after which the patient recovered.Batch numbers of novopen echo, levemir penfill were not available.Action taken to novopen echo was reported as product discontinued due to ae.Action taken to levemir penfill was reported as no change.The outcome for the event "high keytones level up to 4.2(blood ketone body increased)" was recovered.The outcome for the event "novopen echo was not delivering her long acting insulin (levemir)(device failure)" was not reported.No further information available.Preliminary manufacturer's comment: 07-sep-2021: the suspected device novopen echo has not been returned to novo nordisk for evaluation.No conclusion is reached.Company comment: blood ketone body increased is assessed as unlisted event according to the novo nordisk current ccds in levemir penfill.Patient's underlying medical condition of type 1 diabetes mellitus is a significant confounding factor which could have contributed to diabetic ketoacidosis, where blood ketone body increased.However, information regarding any infection, stress and surgery, investigation of the fault device and suspected levemir are unavailable for complete causality assessment.This single case report is not considered to change the current knowledge of the safety profile of levemir penfill.

Event Description

Case description: investigation results : no investigation was possible, because neither sample nor batch number was available.No further information available.Since last submission, the following were updated : inv results updated eu/ca tab updated annexes b,c, d and g updated narrative updated final manufacturer's comment: 03-nov-2021: the suspected device novopen echo has not been returned to novo nordisk for evaluation.Batch number of device is not available, batch trend analysis or reference sample analysis was not performed.With limited information regarding the handling of suspected device, it is not possible to identify a clear root-cause of the experienced adverse event of blood ketone body increased.Patient's underlying medical condition of type 1 diabetes mellitus is a significant confounding factor which could have contributed to diabetic ketoacidosis, where blood ketone body increased.H3 continued: evaluation summary novopen echo, batch number : unknown no investigation was possible, because neither sample nor batch number was available.

Event Description

Case description: batch numbers: novopen echo: fvga581-2.Levemir penfill: not available.Since last submission, the following were updated: batch number of novopen echo updated to fvga581-2.Relevant fields in eu/ca tab updated.Device addendum updated with device narrative updated.Narrative updated accordingly.Final manufacturer's comment: 11-feb-2022: the suspected device novopen echo has been returned to novo nordisk for evaluation.Batch number of device is available, batch trend analysis or reference sample analysis will be performed.With limited information regarding the handling of suspected device, it is not possible to identify a clear root-cause of the experienced adverse event of blood ketone body increased.Patient's underlying medical condition of type 1 diabetes mellitus is a significant confounding factor which could have contributed to diabetic ketoacidosis, where blood ketone body increased.

Event Description

Case description: investigation results : novopen echo® blue - batch fvga581-2.Visual examination and functional testing were performed.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 two lines (- -) 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 device was tested with a random cartridge and a novo nordisk needle.During testing it was possible to deliver preparation from the cartridge.The dose accuracy was also measured using a random cartridge.The results were found to comply with specifications.Note:use a new 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, clogging of the needle may occur.Levemir® penfill® - batch unknown.No investigation was possible, because neither sample nor batch number was available.Since last submission, the following were updated : -investigation results updated.-narrative updated accordingly.Final manufacturer's comment: 01-mar-2022: the suspected device novopen echo has been returned to novo nordisk for evaluation.Upon investigation, device was found to function normal.However, 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 two lines (- -) after the attempted injection.The electronic display is warning the patient that he/she is using the pen wrongly as the patient is injecting with a blocked needle attached.The patient will not receive any insulin and could experience a hyperglycemic event.The observed problem is caused by unintended use of the device.Company comment: blood ketone body increased is assessed as unlisted event according to the novo nordisk current ccds in levemir penfill.Patient's underlying medical condition of type 1 diabetes mellitus is a significant confounding factor which could have contributed to diabetic ketoacidosis, where blood ketone body increased.However, information regarding any infection, stress and surgery are unavailable for complete causality assessment.Use of blocked needle or reuse of needle could have contributed to device malfunction and resultant hyperglycaemia and its complication.This single case report is not considered to change the current knowledge of the safety profile of levemir penfill.H3 continued: evaluation summary: novopen echo® blue - batch fvga581-2.Visual examination and functional testing were performed.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 two lines (- -) 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 device was tested with a random cartridge and a novo nordisk needle.During testing it was possible to deliver preparation from the cartridge.The dose accuracy was also measured using a random cartridge.The results were found to comply with specifications.Note: use a new 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, clogging of the needle may occur.

• 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: 12474429
• MDR Text Key: 271474442
• Report Number: 9681821-2021-00054
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• Reporter Country Code: AS
• 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: 09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2018
• Device Model Number: N/A
• Device Catalogue Number: 185458
• Device Lot Number: FVGA581-2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2021
• Date Manufacturer Received: 02/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2016
• 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
• Treatment: NOVORAPID PENFILL (INSULIN ASPART).; NOVORAPID PENFILL (INSULIN ASPART)
• Patient Outcome(s): Other
• Patient Sex: Female