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

Model Number N/A

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Hypoglycemia (1912)

Event Date 07/01/2021

Event Type  Injury  

Event Description

Serious hypos [hypoglycaemia].The reader at the top simply showing two dashes [device information output issue] extra dose administered [extra dose administered] this serious spontaneous case from the (b)(6) was reported by a consumer as "serious hypos (hypoglycaemia)" with an unspecified onset date, "the reader at the top simply showing two dashes (device image display issue)" with an unspecified onset date, "extra dose administered (extra dose administered)" with an unspecified onset date, and concerned a male patient age(not reported) who was treated with novopen echo (insulin delivery device) from unknown start date for "diabetes mellitus", , novopen echo (insulin delivery device) from unknown start date for "diabetes mellitus", patient height, weight and body mass index not reported.Current condition: diabetes mellitus(type and duration not reported).On an unknown date over the past 6-9 months the pens have become increasingly unreliable, with the reader at the top simply showing two dashes for extended periods of time.This is an intermittent problem (it will work ok for a period of time an then stop working for a similar length of time).A couple of months ago patient asked his doctor for two replacements (which he prescribed), but within about a week getting exactly the same problems again (in both red and blue pens - one for short acting and one for long acting insulin).Patient thought that it has recently caused to overdose.Also patient experienced serious hypos but a couple of weeks ago patient had forgotten whether he took long lasting insulin in the evening, and pen was simply showing two dashes.Patient was convinced that he had not taken evening dose and taken normal dose (extra dose).Patient was awoken at 5 am by his wife as patient was very agitated and was sweating profusely.Blood sugar was 2.2 mmol/l.Patient thought that he had double dosed.Batch number for novopen echo red has been requested.Batch number for novopen echo blue has been requested.Action taken to novopen echo was reported as unknown.The outcome for the event "serious hypos (hypoglycaemia)" was not reported.The outcome for the event "the reader at the top simply showing two dashes (device image display issue)" was not reported.The outcome for the event "extra dose administered (extra dose administered)" was not reported.Preliminary manufacturer's comment: on (b)(6) 2021: the suspected device novopen echo has not been returned to novo nordisk for evaluation.No conclusion is reached.Reporter comment: as a follow up on the email below the envelope to return the faulty pens arrived this morning - i can send these back once replacement pens have been sent to my local pharmacy and i have picked them up.

Event Description

Case description: this serious spontaneous case from the united kingdom was reported by a consumer as "serious hypos(hypoglycaemia)" beginning on 28-jul-2021, "the reader at the top simply showing two dashes(device image display issue)" beginning on jul-2021, "extra dose administered(extra dose administered)" beginning on 28-jul-2021, and concerned a male patient who was treated with novopen echo (insulin delivery device) from unknown start date for "diabetes mellitus", , novopen echo (insulin delivery device) from unknown start date for "diabetes mellitus", , fiasp (insulin aspart) solution for injection, 100 iu/ml, dose, frequency & route used-unknown from unknown start date for "diabetes mellitus", , levemir penfill (insulin detemir) solution for injection,.0024 mol/l, dose, frequency & route used-unknown from unknown start date for "diabetes mellitus", concomitant needle: bd micro-fine ultra pen needles: treatment drug: glucose.Patient thought that on (b)(6) 2021, it caused overdose and the patient experienced serious hypos (blood sugar was 2.7 mmol/l ).It was reported that the patient had forgotten whether he took long lasting insulin in the evening, and pen was simply showing two dashes.Patient was convinced that he had not taken evening dose and taken normal dose (extra dose).Patient was awoken at 5 am by his wife as patient was very agitated and was sweating profusely.Blood sugar was 2.2 mmol/l.Patient thought that he had double dosed.It was reported that although the hypo was quite severe on taking some glucose the hypo symptoms soon passed.Bd micro-fine ultra pen needles 4mm were the needles used.Fiasp and levemir were the insulin used along with novopen echo.Patient used to use the needle usually once sometimes possibly twice and sometimes left the needles attached with the pen.The force needed to inject not felt different from normal.The needles were properly attached to the pen.The patient was trained by a health care professional in the use of suspect product novopen echo.There was no recent changes in diet/omitted meals, physical activity.Batch number for novopen echo was hvgj233-2.Batch number for novopen echo was jvgw591.Batch numbers of fiasp: asku.Batch number of levemir penfill: asku.Action taken to fiasp was not reported.Action taken to levemir penfill was not reported.Since last submission case has been updated with the following: unspecified insulin updated to fiasp penfill and levemir penfill.Concomitant needle added.Onset date of event added.Reporter causality of for the events with novopen echo was updated to probable from unknown.Device narrative updated.Reporter comment updated.Narrative updated accordingly.Preliminary manufacturer's comment: 27-aug-2021: the suspected device novopen echo has been returned to novo nordisk for evaluation.Investigation is ongoing.Reporter comment: the event "serious hypos" was caused by the novo pen echo: probably.

Event Description

Case description: the outcome for the event "serious hypos(hypoglycaemia)" was recovered.Investigational results; name: novopen echo, batch number: hvgj233-2 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.The observed fault is a result of accidental damage during use of the device.Visual examination and functional testing were performed.The memory display showed two lines instead of the last injected dose size.The paint started peeling from the pen cap.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.The device was disassembled to examine internal parts and a microscopic examination was performed.Confirmed: the memory display showed: - - (two lines) after injection and it is not possible to see the last injected dosage in the memory display.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.,the painted surface of the pen is damaged and the paint is swollen and started flaking off.The fault is caused by accidental damage during use of the device.The batch documentation was reviewed.No abnormalities relating to the observed problem were found.The batch documentation has been reviewed and found to be normal.Name: novopen echo, batch number: jvgw591.A visual examination of the returned product was performed.Visual examination and functional testing were performed.The memory display showed two lines instead of the last injected dose size.The paint started peeling on the pen body the dose accuracy was measured by weighing using a random cartridge.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 product was found to be normal.The results were found to comply with specifications.The device was disassembled to examine internal parts and a microscopic examination was performed.Foreign matter was observed in the pen electronics.Confirmed: the memory display showed: - - (two lines) after injection and it is not possible to see the last injected dosage in the memory display.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.The painted surface of the pen is damaged and the paint is swollen and slightly flaking off.The fault is caused by accidental damage during use of the device.The batch documentation was reviewed.No abnormalities relating to the observed problem were found.The batch documentation has been reviewed and found to be normal since last submission case has been updated with following: -investigational result added.-b,c,d,g codes added.-narrative updated accordingly.Final manufacturer's comment: (b)(6) 2021: upon investigation of the returned novopen echo, it was identified that memory function of the device damaged due to corrosion of the electronics as a kind of liquid has entered the pen.The fault is caused by accidental damage during use of the device.The mechanical function of the pen is not affected by the faulty display.In cases where the display turns blank or shows "--" the user is warned that the display is broken and should not be used again.It is possible that patient administered extra dose of insulin due to this display error resulting in hypoglycaemia.Reported event is listed.This single case report is not considered to change the current knowledge of the safety profile of fiasp and levemir penfill.H3 continued: evaluation summary: name: novopen echo, batch number: hvgj233-2.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.The observed fault is a result of accidental damage during use of the device.Visual examination and functional testing were performed.The memory display showed two lines instead of the last injected dose size.The paint started peeling from the pen cap.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.The device was disassembled to examine internal parts and a microscopic examination was performed.Confirmed: the memory display showed: - - (two lines) after injection and it is not possible to see the last injected dosage in the memory display.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.,the painted surface of the pen is damaged and the paint is swollen and started flaking off.The fault is caused by accidental damage during use of the device.The batch documentation was reviewed.No abnormalities relating to the observed problem were found.The batch documentation has been reviewed and found to be normal.

• Brand Name: NOVOPEN ECHO
• Type of Device: INSULIN DELIVERY DEVICE
• Manufacturer (Section D): NOVO NORDISK A/S, MEDICAL SYSTEMS; hilleroed,, ; DA
• MDR Report Key: 12365674
• MDR Text Key: 268085729
• Report Number: 9681821-2021-00043
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• PMA/PMN Number: K123766
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 08/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 185458
• Device Lot Number: HVGJ233-2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2021
• Date Manufacturer Received: 09/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other