MAUDE Adverse Event Report: NOVO NORDISK A/S NOVOPEN 6; INSULIN DELIVERY DEVICE

Model Number N/A

Device Problem Inaccurate Delivery (2339)

Patient Problem Diabetic Ketoacidosis (2364)

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas).Diabetic ketoacidosis (dka) [diabetic ketoacidosis].Had not taken or had not taken correctly his insulin [incorrect dose administered by device].Case description: this serious spontaneous case from the united kingdom was reported by a nurse as "diabetic ketoacidosis (dka)(diabetic ketoacidosis)" with an unspecified onset date, "had not taken or had not taken correctly his insulin(incorrect dose administered by device)" with an unspecified onset date, and concerned a male patient who was treated with novopen 6 (insulin delivery device) from unknown start date for "device therapy", tresiba penfill (insulin degludec) (dose, frequency & route used-unk) from unknown start date for "drug used for unknown indication".Patient height, weight and bmi(body mass index) were not reported.Current condition: diabetes(type and duration not reported).Historical drug: tresiba u100 flex-touch.On an unknown date, prescription changed by a clinical pharmacist from tresiba u100 flex-touch pen to tresiba u100 penfil and novopen 6.Reporter informed that they do not know if the patient had full and proper training as to how to use the pen and cartridge correctly.On an unknown date, the patient experienced diabetic ketoacidosis as the patient had not taken or had not taken correctly his insulin.Batch number of novopen 6 and tresiba penfill were not reported.Action taken to novopen 6 was not reported.Action taken to tresiba penfill was reported as product discontinued.The outcome for the event "diabetic ketoacidosis (dka)(diabetic ketoacidosis)" was unknown.The outcome for the event "had not taken or had not taken correctly his insulin(incorrect dose administered by device)" was unknown.No further information available."this report is for a foreign device that is assessed as "similar" to us marketed novopen echo".

Event Description

Case description: investigation result: novopen® 6 - batch unknown.No investigation was possible, because neither sample nor batch number was available.Tresiba® penfill® (u100) - batch unknown.No investigation was possible, because neither sample nor batch number was available.Since last submission, this case has been updated with the following- investigation result updated.Imdrf annex b, c, d, and g codes updated.Narrative updated accordingly.Final manufacturer's comment: 06-dec-2023: the suspected device novopen 6 has not been returned to novo nordisk for evaluation.Batch number of the device unavailable despite repeated efforts to find the same.No batch trend analysis or reference sample analysis performed.No other confounding factors identified.With the available limited information regarding the handling of the suspected device, it is not possible to identify a clear root cause in relation to functionality of novopen 6.H3 continued: evaluation summary: novopen® 6 - batch unknown.No investigation was possible, because neither sample nor batch number was available.

• Brand Name: NOVOPEN 6
• Type of Device: INSULIN DELIVERY DEVICE
• Manufacturer (Section D): NOVO NORDISK A/S; bagsvaerd,, ; 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: 18065963
• MDR Text Key: 327292943
• Report Number: 9681821-2023-00149
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• Reporter Country Code: UK
• PMA/PMN Number: K123766
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2023
• 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: 12/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Hospitalization
• Patient Sex: Male