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

Model Number N/A

Device Problems Defective Component (2292); Inaccurate Delivery (2339); Device Displays Incorrect Message (2591)

Patient Problem Diabetic Ketoacidosis (2364)

Event Type  Injury  

Event Description

Event verbatim [preferred term], (related symptoms if any separated by commas).Serious glycaemic decompensations [diabetic metabolic decompensation], novo pen echo and novo pen echo plus, that were not dosing the right amounts of insulin [device delivery system issue].Displaying errors on the pens [device information output issue].Insulin vials are not protected at all.And keep on breaking the moment the pen falls on the ground [device issue].Case description: this serious spontaneous case from poland was reported by a physician as "serious glycaemic decompensations (diabetic metabolic decompensation)" with an unspecified onset date, "novo pen echo and novo pen echo plus that were not dosing the right amounts of insulin (inaccurate delivery by device)".With an unspecified onset date, "displaying errors on the pens (device image display error)".With an unspecified onset date, "insulin vials are not protected at all.And keep on breaking the moment the pen falls on the ground (device component issue)".With an unspecified onset date, and concerned a (age not reported) female patient who was treated with novopen echo plus (insulin delivery device), from unknown start date for "type 1 diabetes mellitus", novopen echo (insulin delivery device), from unknown start date for "type 1 diabetes mellitus", tresiba penfill 100 u/ml (insulin degludec) (dose, frequency & route used- unk, subcutaneous) from unknown start date for "type 1 diabetes mellitus", fiasp penfill (insulin aspart), (dose, frequency & route used- unk, subcutaneous) from unknown start date for "type 1 diabetes mellitus".The patient's height, weight and body mass index (bmi) were not reported.Current condition: diabetes mellitus type 1 (duration was not reported).On an unspecified date, patient change the insulin pump treatment back to the multi-injection pen therapy using the insulin fiasp tresiba, and the novopen echo and novopen echo plus pens.Pen was used by the patient for some months.On an unspecified date, patient experienced some serious glycaemic decompensations over weeks.It was reported, that patient encountered many problems concerning use of novopen echo and novopen echo plus pens.Due to faulty novo pen echo and novo pen echo plus device, pen were not dosing the right amounts of insulin.And later on, displaying errors on the pens themselves.It was reported, that the insulin vials are not protected at all.And keep on breaking the moment.The pen falls on the ground (which in her opinion was not the case at all in the pens novo nordisk offered 10-20 years ago).Batch numbers: novopen echo plus: unknown, novopen echo: unknown, tresiba penfill 100 u/ml: asku, fiasp penfill: asku.Action taken to novopen echo plus was reported as product discontinued.Action taken to novopen echo was reported as product discontinued.Action taken to tresiba penfill 100 u/ml was reported as unknown.Action taken to fiasp penfill was reported as unknown.The outcome for the event: "serious glycaemic decompensations (diabetic metabolic decompensation)" was unknown.The outcome for the event: "novo pen echo and novo pen echo plus that were not dosing the right amounts of insulin (inaccurate delivery by device)" was not reported.The outcome for the event: "displaying errors on the pens (device image display error)" was not reported.The outcome for the event: "insulin vials are not protected at all.And keep on breaking the moment, the pen falls on the ground (device component issue)" was not reported.

Event Description

Case description: investigation result: name novopen® echo® plus batch no: mvg9a73.The number of complaints on the batch was evaluated and, when applicable, relevant actions were taken.The product was not returned for examination.If possible, please forward the reported product(s) for further investigations.Name:novopen echo® batch no: unknown.No investigation was possible, because neither sample nor batch number was available.If possible, please forward the reported product(s) for further investigations.Since last submission following has been updated.Inv results were updated.Annex b, c, d, g codes were updated.Narrative was updated accordingly.References included: reference type: e2b company number.Reference id#: (b)(4).Reference notes: reference type: mw 3500a mfr.Rpt.#.Reference id#: (b)(4).Reference notes: medwatch 3500a mfr.Report number.Reference type: mw 3500a mfr.Rpt.#.Reference id#: (b)(4).Reference notes: medwatch 3500a mfr.Report number.H3 continued: evaluation summary.Name:novopen echo® batch no: unknown.No investigation was possible, because neither sample nor batch number was available.If possible, please forward the reported product(s) for further investigations.

• 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: 18854115
• MDR Text Key: 337071972
• Report Number: 9681821-2024-00038
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• Reporter Country Code: PL
• PMA/PMN Number: K123766
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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): Life Threatening
• Patient Sex: Female