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

Model Number N/A

Device Problem No Flow (2991)

Patient Problem Hyperglycemia (1905)

Event Type  Injury  

Event Description

[preferred term] (related symptoms if any separated by commas).High blood sugar [blood glucose increased].No insulin came out when pressing the dose button [device failure].Pen did not worked, had to borrow insulin from someone else [prescription drug used without a prescription].Case description: this serious spontaneous case from norway was reported by a health care professional nos as "high blood sugar (blood sugar increased)" with an unspecified onset date, "no insulin came out when pressing the dose button (device failure)" with an unspecified onset date, "pen did not worked, had to borrow insulin from someone else(prescription drug used from another patient)" with an unspecified onset date, and concerned a female patient (born in the year 1967) 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 was not reported.Medical history was not provided.On an unknown date, patient found out that the pen did not work - no insulin came out when pressing the dose button.As a consequence patient experienced very high blood sugar (around 30mmol/l) and had to borrow insulin from someone else.Batch numbers: novopen 6: lvg5b84-1.The outcome for the event "high blood sugar (blood sugar increased)" was unknown.The outcome for the event "no insulin came out when pressing the dose button (device failure)" was unknown.The outcome for the event "pen did not worked, had to borrow insulin from someone else (prescription drug used from another patient)" was not reported.Event onset date is not reported in the case.However, the incident dates are captured to ensure the mir form is generated."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, batch number: lvg5b84-1.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 liquid stains.The observed problem was not related to any novo nordisk processes and it was a result of accidental damage during use of the device.The number of complaints on the batch was evaluated and, when applicable, relevant actions were taken.The electronic register was checked.Several codes in the logs indicates that the memory display had showed error during use.Visual examination and functional testing were performed.Upon receipt the memory display was showing error.The mechanic pen mechanism was found to be function normal.During test the memory display mirrored the dialled units.The dose selector was slightly tilted.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 device was disassembled to examine internal parts.Microscopic examination performed.No remarks.The electronic display showed "error" after the dose button was fully depressed.This was a normal function of the pen to warn the user of non-recommended user behaviour.The user split the selected dose into two or more smaller doses which were delivered over a period of more than 15 minutes.The error was caused by unintended use of the device.The fault observed is potentially affecting the battery duration; however, it does not have influence on the mechanical functionality of the product.The battery was discharged due to unintended misalignment of the two end of dose switches.The fault was due to an error at novo nordisk.Final manufacturer's comment: 01-mar-2024: the suspected device novopen 6 has been returned to novo nordisk for evaluation.Except for dust on outer surface, device was found to work normally as per the specifications.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.Investigation result added imdrf code added relevant fields updated in eu/ca tab narrative updated accordingly 08-mar-2024: since last submission, a correction has been done in mir form.Current location of device has been changed from unknown to manufacturer as the device has been returned to novo nordisk and investigated.H3 continued: evaluation summary name: novopen® 6, batch number: lvg5b84-1.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 liquid stains.The observed problem was not related to any novo nordisk processes and it was a result of accidental damage during use of the device.The number of complaints on the batch was evaluated and, when applicable, relevant actions were taken.The electronic register was checked.Several codes in the logs indicates that the memory display had showed error during use.Visual examination and functional testing were performed.Upon receipt the memory display was showing error.The mechanic pen mechanism was found to be function normal.During test the memory display mirrored the dialled units.The dose selector was slightly tilted.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 device was disassembled to examine internal parts.Microscopic examination performed.No remarks.The electronic display showed "error" after the dose button was fully depressed.This was a normal function of the pen to warn the user of non-recommended user behaviour.The user split the selected dose into two or more smaller doses which were delivered over a period of more than 15 minutes.The error was caused by unintended use of the device.The fault observed is potentially affecting the battery duration; however, it does not have influence on the mechanical functionality of the product.The battery was discharged due to unintended misalignment of the two end of dose switches.The fault was due to an error at novo nordisk.

• 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: 18578220
• MDR Text Key: 333661398
• Report Number: 9681821-2024-00018
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K123766
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 08/31/2023
• Device Model Number: N/A
• Device Lot Number: LVG5B84-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2021
• 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: Female