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

Model Number N/A

Device Problem Inaccurate Delivery (2339)

Patient Problems Hyperglycemia (1905); Diabetic Ketoacidosis (2364)

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas) had acetone in his blood [blood ketone body increased] hyperglycemia [hyperglycaemia] after pressing the dose counter the pen doesn't inject all the insulin amounts [device delivery system issue] case description: this serious spontaneous case from egypt was reported by a patient family member or friend as "had acetone in his blood(blood ketone body increased)" with an unspecified onset date, "hyperglycemia(hyperglycemia)" with an unspecified onset date, "after pressing the dose counter the pen doesn't inject all the insulin amounts(inaccurate delivery by device)" with an unspecified onset date, and concerned a male patient who was treated with novopen 4 (insulin delivery device) from unknown start date for "device therapy", novorapid penfill (insulin aspart) (dose, frequency & route used-unk) from unknown start date for "diabetes mellitus".Patient height, weight and body mass index not mentioned current condition: diabetes mellitus.(type and duration not mentioned) on an unknown date the patient had suffered from hyperglycemia and had acetone in his blood due to the technical problem of patients novopen 4 ( using novorapid penfill ), after pressing the dose counter the pen doesn't inject all the insulin amounts pen training was offered but the patient refused to perform the steps batch numbers: novopen 4: lvg5b14 novorapid penfill: was requested action taken to novorapid penfill was not reported.The outcome for the event "had acetone in his blood(blood ketone body increased)" was not reported.The outcome for the event "hyperglycemia(hyperglycemia)" was not reported.The outcome for the event "after pressing the dose counter the pen doesn't inject all the insulin amounts(inaccurate delivery by device)" was not reported.Preliminary manufacturer's comment: (b)(6) 2023: the suspected device novopen 4 has not been returned for evaluation.No conclusion is reached.

Event Description

Case description: investigation results: novopen 4, batch number: lvg5b14.The product was not returned for examination.Since last submission the case has been updated with the following: imdrf codes and investigation results added, relevant fields in eu/ca tab updated, narrative was updated accordingly.Final manufacturer's comment: 16-may-2023: the suspected device novopen 4 has not been returned for evaluation.The batch trend analysis and reference sample examination revealed nothing abnormal.No abnormalities relating to the observed problem were found.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 4.Events are listed.This single case report is not considered to change the current knowledge of the safety profile of novorapid penfill.H3 continued: evaluation summary: novopen 4, batch number: lvg5b14.The product was not returned for examination.

• 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: 16782860
• MDR Text Key: 313707513
• Report Number: 9681821-2023-00058
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• Reporter Country Code: EG
• PMA/PMN Number: 20-986
• 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: 04/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: N/A
• Device Catalogue Number: 185490
• Device Lot Number: LVG5B14
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2021
• 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: Male