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

Model Number N/A

Device Problems Mechanical Jam (2983); No Flow (2991)

Patient Problem Hyperglycemia (1905)

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas) hyperglycemia [hyperglycaemia] does not inject insulin due to piston rod movement issue [device failure] piston rod movement issue [device mechanical issue] case description: this serious spontaneous case from egypt was reported by a patient family member or friend as "hyperglycemia(hyperglycemia)" with an unspecified onset date, "does not inject insulin due to piston rod movement issue(device failure)" with an unspecified onset date, "piston rod movement issue(device mechanical jam)" with an unspecified onset date, and concerned a 43 years old male patient who was treated with novopen 4 (insulin delivery device) from unknown start date for "diabetes mellitus", novorapid penfill (insulin aspart) (dose, frequency & route used- 8-10u/breakfast, 12-15u/lunch, 8-9u/dinner, subcutaneous and regimen #2: 5u, subcutaneous mr7fy78 11/--/2024) from apr-2023 and ongoing for "diabetes mellitus", patient's height: 167 cm patient's weight: 70 kg patient's bmi: 25.09950160.Dosage regimens: novopen 4: novorapid penfill: apr-2023 to not reported (dosage regimen ongoing), not reported to not reported; current condition: diabetes ((b)(6) 2023, duration not reported), digestion procedure: pancreatectomy.Concomitant products included - toujeo(insulin glargine), creon 25000(pancreatin), vitamin (not specified) (non-codable) on an unknown date, patient suffered from hyperglycemia due to technical issue in his pen.The patient's blood glucose (blood glucose) level before the dinner was 385mg/dl, it supposed to take 5u before the dinner (patient did not take it due to pen issue, did know that the pen was not working) and after dinner blood glucose (blood glucose) level was 516 mg/dl, so she determined that he didn't take the insulin dose.Later, the patient completely recovered after the patient took 5u as his blood glucose(blood glucose) level decreased to 270mg/dl after 2.5 hours from taking the dose.The reporter stated that her husband faced a problem with his novopen as it does not inject insulin due to piston rod movement issue.She said that the piston rod head was not well fixed with the piston rod, she was informed that it was normal pen training was offered and during it, the mechanical part and the piston rod moved normally after adjusting the dose counter to 60u and pressing the dose button.She did not have a new penfill and new needle during the call, so follow up call was offered but she said that she will contact the hotline again to complete the pen training steps.It was reported that hba1c (glycosylated haemoglobin) was 9.3 (units not reported) (after diagnosis, patient did not do new test), rbgl(blood glucose): 76mg/dl.Batch numbers: novopen 4: mvg8b67 novorapid penfill: mr7fy78 the outcome for the event "hyperglycemia(hyperglycemia)" was recovered.The outcome for the event "does not inject insulin due to piston rod movement issue(device failure)" was not reported.The outcome for the event "piston rod movement issue(device mechanical jam)" was not reported.Preliminary manufacturer's comment: 30-nov-2023: the suspected device novopen 4 has not been returned to novo nordisk for evaluation.No conclusion is reached.

• 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: 18354638
• MDR Text Key: 330872719
• Report Number: 9681821-2023-00173
• 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: 11/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: N/A
• Device Catalogue Number: 185490
• Device Lot Number: MVG8B67
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2022
• 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
• Treatment: CREON 25000 (PANCREATIN) 04/--/2023 TO UNK; TOUJEO (INSULIN GLARGINE) ONGOING
• Patient Outcome(s): Other
• Patient Age: 43 YR
• Patient Sex: Male
• Patient Weight: 70 KG