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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Diabetic Ketoacidosis (2364)

Event Date 09/07/2019

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas).Ketoacidosis [diabetic ketoacidosis].Ketoacidosis occured despite injections [device failure].Used the dialling clicks to estimate the dose [wrong technique in device usage process].Limb pain [pain in extremity].Case description: this serious spontaneous case from (b)(6) was reported by a consumer as "ketoacidosis" beginning on (b)(6) 2019, "ketoacidosis occured despite injections" with an unspecified onset date, "used the dialling clicks to estimate the dose" with an unspecified onset date, "limb pain" beginning on (b)(6) 2019, and concerned a (b)(6) years old female patient who was treated with novopen echo (insulin delivery device) from unknown start date due to "type 1 diabetes mellitus", , protaphane penfill (insulin human) from unknown start date due to "type 1 diabetes mellitus" (dose and frequency unknown), , novorapid penfill (insulin aspart) from unknown start date due to "type 1 diabetes mellitus" (dose and frequency unknown), patient's height: 182 cm.Patient weight and body mass index were not reported.Medical history included type 1 diabetes mellitus (since (b)(6) 2016).On (b)(6) 2019, patient experienced ketoacidosis, nausea, vomiting and limb pain during the use of novopen echo and it all recovered on (b)(6) 2019.On an unknown date patient started using protaphane and novorapid.Treatment received was reported.On an unknown date, patient experienced ketoacidosis despite injections and also the patient used dialing clicks to estimate the dose during use of novopen echo.On an unknown date, patient blood glucose was 400 mg/dl and blood ketones was 4.9 (unit not reported).Batch number of novopen echo was available.Action taken to novopen echo was not reported.Action taken to protaphane penfill was not reported.Action taken to novorapid penfill was not reported.The outcome for the event "ketoacidosis" was recovered.The outcome for the event "ketoacidosis occured despite injections" was not reported.The outcome for the event "used the dialling clicks to estimate the dose" was not reported.On (b)(6) 2019 the outcome for the event "limb pain" was recovered.Reporter comment: treatment for the event: yes, trinking a lot.Technical problem led to the diabetic ketoacidosis cannot be ruled out, therefore we sent the used pens for examination.We didn't recognize a technical/mechanical problem of the pens.

Event Description

Case description: on (b)(6) 2019, patient experienced nausea, vomiting and limb pain during the use of novopen echo.During the event patient's blood glucose was reported as 400 mg/dl and blood ketones was reported as 4.9 (unit not reported).Patient was diagnosed with ketoacidosis despite injections.Treatment received was reported as drinking a lot of water.Also, after the event the dose of protaphane was adjusted and use of the suspected device was stopped.The adjustment of the protaphane dose significantly contributed to the stabilization of the patient's values.Patient used dialing clicks to estimate the dose during use of novopen echo.Patient attached the needle to the pen in a 180-degree angle.Patient re-suspends insulin suspension before use.Patient stored the insulin in use at room temperature 20 - 25 °c.During the time of event novopen echo and novopen 5 were used simultaneously.It was reported that no lack of efficacy was suspected with both protaphane penfill and novorapid penfill.After the event measuring device, pens were exchanged, new insulin was used and use of the suspected device was stopped.Batch number of novopen echo was available, protaphane penfill and novorapid penfill was unknown.On (b)(6) 2019 outcome for the event "ketoacidosis" was recovered.The outcome for the event "ketoacidosis occured despite injections" was not reported.The outcome for the event "used the dialling clicks to estimate the dose" was not reported.On (b)(6) 2019 the outcome for the event "limb pain" was recovered.Investigational results: name: novopen echo.Batch number : gvgg433-1.The batch documentation was reviewed.The electronic register was checked.The readout revealed indications of use of the pen with no flow in the delivery system.Visual and functional examinations were performed and 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 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.After the injection to follow the attempted 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 memory display showed - - (two lines) after injection.The observed problem does not influence the mechanical functions of the pen.The observed problem was caused by interference from foreign matter entering the pen and is due to accidental handling during use.Name: novorapid penfill, batch number: unknown.No investigation was possible, because neither sample nor batch number was available.Name: protaphane penfill, batch number: unknown.No investigation was possible, because neither sample nor batch number was available.Since last submission the case has been updated with the following: reporter's causality updated to unlikely for novopen echo.The case is linked with argus case number (b)(4).Manufacturer comment: 14-oct-2019: upon investigation of the returned device (novopen echo, batch no.Gvgg433-1), 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.After the injection to follow the attempted 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 memory display showed - - (two lines) after injection.The observed problem does not influence the mechanical functions of the pen.Diabetic ketoacidosis is listed, pain in limbs is unlisted according to the novo nordisk current ccds in protophane penfill and novorapid penfill.This single case report is not considered to change the current knowledge of the safety profile of protophane penfill and novorapid penfill.Reporter comment: from our point of view today the adjustment of the protaphane dose significantly contributed to the stabilization of the patient's values.We are convinced that the pens were not the triggers at the time of the event.H3 continued: evaluation summary.Investigational results.Name: novopen echo - batch gvgg433-1.The batch documentation was reviewed.The electronic register was checked.The readout revealed indications of use of the pen with no flow in the delivery system.Visual and functional examinations were performed and 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 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.After the injection to follow the attempted 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 memory display showed - - (two lines) after injection.The observed problem does not influence the mechanical functions of the pen.The observed problem was caused by interference from foreign matter entering the pen and is due to accidental handling during use.

Event Description

Case description: investigational results.Name: novopen echo - batch gvgg433-1.The batch documentation was reviewed.No abnormalities relating to the observed problem were found.The batch documentation has been reviewed.Nothing abnormal was found.The electronic register was checked.The readout revealed indications of use of the pen with no flow in the delivery system.Visual and functional examinations were performed and 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 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.After the injection to follow the attempted injection the pen will function as normal again, if a new injection needle was mounted on the pen immediately before the injection.The observed problem was caused by unintended use of the device.The memory display showed - - (two lines) after injection.The observed problem does not influence the mechanical functions of the pen.The observed problem was caused by interference from foreign matter entering the pen and was due to accidental handling during use since last submission the case has been updated with the following: -is non-reportable updated.-wwid number added(case is a master made from existing duplicates in eudravigilance by the ema duplicate management team.The case numbers of the underlying duplicates are in the other case identifiers section).-investigation result added.-imdrf code added.-relevant fields updated in eu/ca tab and m/w form.-narrative updated accordingly.H3 continued: evaluation summary.Investigational results: name: novopen echo - batch gvgg433-1.The batch documentation was reviewed.No abnormalities relating to the observed problem were found.The batch documentation has been reviewed.Nothing abnormal was found.The electronic register was checked.The readout revealed indications of use of the pen with no flow in the delivery system.Visual and functional examinations were performed and 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 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.After the injection to follow the attempted injection the pen will function as normal again, if a new injection needle was mounted on the pen immediately before the injection.The observed problem was caused by unintended use of the device.The memory display showed - - (two lines) after injection.The observed problem does not influence the mechanical functions of the pen.The observed problem was caused by interference from foreign matter entering the pen and was due to accidental handling during use.

• 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
• Manufacturer Contact: p.o. box 846; plainsboro, NJ 08536 ; 8007276500
• MDR Report Key: 9177072
• MDR Text Key: 162601347
• Report Number: 9681821-2019-00067
• 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
• Report Date: 09/11/2019
• 2 Devices were Involved in the Event: 1 2

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: 08/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 185459
• Device Lot Number: GVGG433-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2019
• Initial Date Manufacturer Received: 09/11/2019
• Initial Date FDA Received: 10/10/2019
• Supplement Dates Manufacturer Received: 10/07/2019; 03/06/2024
• Supplement Dates FDA Received: 11/05/2019; 04/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2017
• 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: 16 YR
• Patient Sex: Female