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

Model Number N/A

Device Problems Inaccurate Delivery (2339); Mechanical Jam (2983)

Patient Problem Hyperglycemia (1905)

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas).Hyperglycemia [hyperglycaemia].Pen injection not accurate [device delivery system issue].When pressed on dose button,the piston rod not moved [device mechanical issue].Case description: this serious spontaneous case from egypt was reported by a consumer as "hyperglycemia(hyperglycemia)" with an unspecified onset date, "pen injection not accurate(inaccurate delivery by device)" with an unspecified onset date, "when pressed on dose button,the piston rod not moved(device mechanical jam)" with an unspecified onset date, and concerned a female patient (age was not reported) who was treated with novopen 4 (insulin delivery device) from unknown start date for "device therapy", the patient's height, weight, and body mass index (bmi) were not reported.Medical history was not provided.On an unknown date, patient's pen injection was not accurate due to which the patient suffered from hyperglycemia, was directed to hospital and was admitted (duration of hospitalization was not reported).The doctor said the patient does not take insulin, also mentioned didn't use that pen before and that was the first use then took her dose by syringe.It was reported that pen training was offered and during it the piston rod moved normally when directed the mechanical part to the gravity then asked patient to adjust dose counter on 60 u then press on dose button, the piston rod not moved (6 times), so asked patient to move it by hands manually then asked to add newpenfill but refused it and refused to complete pen training.Patient was informed to take the dose by syringe until the problem of pen was solved but patient refused and said that didn't received any pen training.Batch numbers: novopen 4: nvgbf64.The outcome for the event "hyperglycemia(hyperglycemia)" was not reported.The outcome for the event "pen injection not accurate(inaccurate delivery by device)" was not reported.The outcome for the event "when pressed on dose button,the piston rod not moved(device mechanical jam)" was not reported.No further information available.Reporter comment: patient returned to hcp (health care professional) and changed the insulin type and does not need that pen anymore, so was not informed by technical details.

• 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: 18491332
• MDR Text Key: 332614521
• Report Number: 9681821-2024-00009
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• 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
• Report Date: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 185490
• Device Lot Number: NVGBF64
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2023
• 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 Sex: Female