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 Problem Hypoglycemia (1912)

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas).Hypoglycemic crisis [hypoglycaemia].Cannot disassemble the pen [device malfunction].Case description: this serious spontaneous case from brazil was reported by a consumer as "hypoglycemic crisis(hypoglycemia)" with an unspecified onset date, "cannot disassemble the pen(device malfunction)" 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", , fiasp (insulin aspart) (dose, frequency & route used-unk) from unknown start date for "drug use for unknown indication", novolin n (insulin human) (dose, frequency & route used-unk) from unknown start date for "drug use for unknown indication".Patient's height, weight and body mass index (bmi) were not reported.Medical history was not provided.Concomitant products included - pantoprazole, xarelto(rivaroxaban), metformin.On an unknown day, the patient had a hypoglycemic crisis and the patient's daughter set up the pen to perform the application, and could not disassemble the pen.It was informed that the hypoglycemic crisis had no relation with the medications the flowtest was successfully performed.Batch number of novopen 4, fiasp and novolin n has been requested.Action taken of novpen 4 was not reported.Action taken to fiasp was not reported.Action taken to novolin n was not reported.The outcome for the event "hypoglycemic crisis(hypoglycemia)" was not reported.The outcome for the event "cannot disassemble the pen(device malfunction)" was not reported.

Event Description

Case description: investigation results.Name novopen 4 batch number:unknown.No investigation was possible, because neither sample nor batch number was available.Fiasp® - batch unknown.No investigation was possible, because neither sample nor batch number was available.Novolin® n - batch unknown.No investigation was possible, because neither sample nor batch number was available.Since last submission the case has been updated with the follwing: -imdrf codes added.-investigation result added.-narrative updated accordingly.Final manufacturer's comment: 17-mar-2023: the suspected device (novopen 4) has not been returned to novo nordisk a/s for the investigation.Batch number of device is not available, no batch trend analysis or reference sample analysis performed.No 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 fiasp and novolin n.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: 16213028
• MDR Text Key: 307767045
• Report Number: 9681821-2023-00013
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• Reporter Country Code: BR
• 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: 01/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2023
• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/17/2023
• 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
• Treatment: METFORMIN (METFORMIN).; PANTOPRAZOLE (PANTOPRAZOLE).; XARELTO (RIVAROXABAN).
• Patient Outcome(s): Other
• Patient Sex: Male