MAUDE Adverse Event Report: NOVO NORDISK A/S, MEDICAL SYSTEMS NOVOPEN 4; INSULIN DELIVERY DEVICE

Model Number N/A

Device Problems Inaccurate Delivery (2339); Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas).Hospitalisation.Faulty pen (against 35 units of tresiba 140 units got injected).[device delivery system issue].Case description: this serious spontaneous case from india was reported by a consumer as "hospitalisation" with an unspecified onset date, "faulty pen (against 35 units of tresiba 140 units got injected) (inaccurate delivery by device)" with an unspecified onset date, and concerned a male patient (age not reported) who was treated with novopen 4 (insulin delivery device) from unknown start date for "device therapy", tresiba penfill 100u (insulin degludec) (dose, frequency & route used- 35 units of tresiba 140 units got injected) from unknown start date for "product used for unknown indication", patient height, weight, and body mass index were not reported.Medical history was not provided.On an unknown date, patient's novopen 4 was faulty and administered 140 unit of tresiba instead of 35 unit.So doctor admitted the patient on (b)(6) 2023 as a precaution.The patient was under observation for 1 day and got discharged on saturday - 18-nov-2023, it was reported that, based on doctors request , patient replaced novopen-4.Batch numbers: novopen 4: evg6017-1.Tresiba penfill 100u: requested.Action taken to novopen was not reported.Action taken to tresiba penfill 100u was not reported.The outcome for the event "hospitalisation(hospitalisation)" was not reported.The outcome for the event "faulty pen (against 35 units of tresiba 140 units got injected)(inaccurate delivery by device)" was unknown.Company comment: hospitalisation is assessed as unlisted event according to the novo nordisk current ccds in tresiba penfill.Relevant information on final diagnosis, indication for hospitalization, lab test results, treatment given and investigation results of returned sample are unavailable for complete causality assessment.This single case report is not considered to change the current knowledge of the safety profile of tresiba penfill.

Event Description

Investigation results: novopen 4 - batch evg6017-1 visual examination and functional testing were performed.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 number of complaints on the batch was evaluated and, when applicable, relevant actions were taken.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.During examination of the product, no irregularities related to the complaint were detected.Tresiba penfill - batch unknown no investigation was possible, because neither sample nor batch number was available.Since last submission the case has been updated with following: -investigation results updated.-annex, b, c d and g codes added.-narrative has been updated accordingly.Final manufacturer's comment: 31-mar-2024: the suspected device novopen 4 has been returned to novo nordisk for evaluation.During examination of the product, no irregularities related to the complaint were detected.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.Since no faults were found on the returned device novopen 4 and only very limited information regarding the patients handling of the suspected device is reported in the case, it is not possible to elucidate a clear root cause for the experienced adverse event leading to hospitalization.H3 continued: evaluation summary novopen 4 - batch evg6017-1 visual examination and functional testing were performed.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 number of complaints on the batch was evaluated and, when applicable, relevant actions were taken.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.During examination of the product, no irregularities related to the complaint were detected.

• Brand Name: NOVOPEN 4
• Type of Device: INSULIN DELIVERY DEVICE
• Manufacturer (Section D): NOVO NORDISK A/S, MEDICAL SYSTEMS; hilleroed,, ; DA
• Manufacturer (Section G): NOVO NORDISK A/S, MEDICAL SYSTEMS; brennum park; hilleroed,, 3400 ; DA 3400
• Manufacturer Contact: p.o. box 846; plainsboro, NJ 08536 ; 8007276500
• MDR Report Key: 18677003
• MDR Text Key: 335075924
• Report Number: 9681821-2024-00029
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• Reporter Country Code: IN
• PMA/PMN Number: 20-986N/A
• 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: 01/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 09/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 185490
• Device Lot Number: EVG6017-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2023
• Date Manufacturer Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2015
• 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): Hospitalization
• Patient Sex: Male