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 Diabetic Ketoacidosis (2364)

Event Date 10/02/2022

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas).Patient had ketoacidosis, the patient was in a semi-coma.Blood glucose was very high [diabetic ketoacidosis].Pen had a problem [device issue].As the pen has problem insufficient injection each time.[device delivery system issue].Case description: this serious spontaneous case from china was reported by a consumer as "patient had ketoacidosis, the patient was in a semi-coma.Blood glucose was very high(diabetic ketoacidosis)" beginning on (b)(6) 2022, "pen had a problem(device issue)" beginning on (b)(6) 2022, "as the pen has problem insufficient injection each time.(inaccurate delivery by device)" beginning on (b)(6) 2022, and concerned a 46 years old female patient who was treated with novopen 4 (insulin delivery device) from unknown start date for "type 2 diabetes mellitus", novomix 30 penfill (insulin aspart) (dose, frequency & route used-26 iu, qd (8 u in the morning, 9 u at noon and 9 u in the evening)) from unknown start date for "type 2 diabetes mellitus".Patient's height: 168 cm.Patient's weight: 60 kg.Patient's bmi: 21.25850340.Dosage regimens: novopen 4: null.Novomix 30 penfill: null.Current condition: type 2 diabetes mellitus (for more than 2 years).On (b)(6) 2022, patient was hospitalized for 14 days due to diabetic ketoacidosis along with semi-coma and high blood glucose levels.During hospitalization, the doctor judged that the pen had a problem, which led to insufficient injection dose each time.The patient changed it to new pen and after receiving the previous novopen 4, the hotline confirmed that there was a problem with the parts of the pen.Batch numbers of novopen 4 and novomix 30 penfill were requested.Action taken to novopen 4 was reported as product discontinued due to ae.Action taken to novomix 30 penfill was reported as not applicable.The outcome for the event "patient had ketoacidosis, the patient was in a semi-coma.Blood glucose was very high(diabetic ketoacidosis)" was not reported.The outcome for the event "pen had a problem(device issue)" was not reported.The outcome for the event "as the pen has problem insufficient injection each time.(inaccurate delivery by device)" was not reported.Preliminary manufacturer's comment 07-apr-2023: the suspected device has not been returned to novonordisk for evaluation.No conclusion is reached.

Event Description

Case description: investigation results: novopen 4 - batch unknown no investigation was possible, because neither sample nor batch number was available.Novomix 30 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.-imdrf codes added.-narrative has been updated accordingly final manufacturer's comment 02-jun-2023: the suspected device novopen 4 has not been returned to novo nordisk for investigation.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 4.Events are listed.This single case report is not considered to change the current knowledge of the safety profile of novomix 30 penfill.H3 continued: evaluation summary novopen 4 - batch unknown no investigation was possible, because neither sample nor batch number was available.

• 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: 16731958
• MDR Text Key: 313209918
• Report Number: 9681821-2023-00054
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• Reporter Country Code: CH
• 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: 04/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: N/A
• Device Catalogue Number: 185490
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/28/2023
• 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 Age: 46 YR
• Patient Sex: Female
• Patient Weight: 60 KG