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

Model Number N/A

Device Problems Display or Visual Feedback Problem (1184); Inaccurate Delivery (2339)

Patient Problem Hyperglycemia (1905)

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas).Blood glucose level rose to 5g [blood glucose increased], pen often shows "error" [device information output issue], patient thinks that the pen is not injecting the complete dose [incorrect dose administered by device].Case description: this serious spontaneous case from france was reported by a consumer as "blood glucose level rose to 5g(blood glucose increased)" with an unspecified onset date, "pen often shows "error"(device image display error)" with an unspecified onset date, "patient thinks that the pen is not injecting the complete dose(partial dose delivery 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 "product used for unknown indication", patient's height, weight and body mass index(bmi) was not reported.Dosage regimens: novopen 6: medical history was not provided.On an unknown date, the patient reported that his pen often shows "error" and the patient thinks that the pen is not injecting the complete dose.On an unknown date of last week, the patient reported that blood glucose level (blood glucose) rose to 5g.Batch numbers: novopen 6: mvg8t22.Action taken to novopen 6 was reported as unknown.The outcome for the event "blood glucose level rose to 5g(blood glucose increased)" was unknown.The outcome for the event "pen often shows "error"(device image display error)" was not reported.The outcome for the event "patient thinks that the pen is not injecting the complete dose(partial dose delivery by device)" was unknown.Preliminary manufacturer's comment: 26-jul-2023: the suspected device novopen 6 has not been returned to novonordisk for evaluation.No conclusion is reached."this report is for a foreign device that is assessed as "similar" to us marketed novopen echo".

Event Description

Case description: investigational result: name: novopen® 6 argent, batch number: mvg8t22 the number of complaints on the batch was evaluated and, when applicable, relevant actions were taken.The product was not returned for examination.Since last submission, this case has been updated with the following investigation result added.Imdrf code added.Relevant fields updated in eu/ca tab.Narrative updated accordingly.Final manufacturer's comment: 04-aug-2023: the suspected device novopen 6 has not been returned to novonordisk for evaluation.No abnormalities relating to the observed problem were found in the reference sample analysis.The batch documentation has been reviewed and found to be normal.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.

• 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: 17498619
• MDR Text Key: 320793257
• Report Number: 9681821-2023-00109
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Report Date: 07/17/2023

1 Device was Involved in the Event

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 Model Number: N/A
• Device Lot Number: MVG8T22
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/17/2023
• Initial Date FDA Received: 08/10/2023
• Supplement Dates Manufacturer Received: 08/29/2023
• Supplement Dates FDA Received: 09/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2022
• 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 Sex: Male