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 Hyperglycemia (1905)

Event Type  Injury  

Event Description

Suffered from hyperglycemia due to her novopen 4 issue [hyperglycaemia].Novopen 4 did not inject insulin [device failure].Case description: this serious spontaneous case from egypt was reported by a consumer as "suffered from hyperglycemia due to her novopen 4 issue (hyperglycemia)" with an unspecified onset date, "novopen 4 did not inject insulin (device failure)" with an unspecified onset date, and concerned a female patient who was treated with novopen 4 (insulin delivery device) from unknown start date for "device therapy", novorapid penfill (insulin aspart) from unknown start date for "drug used for unknown indication." patient height, weight and bmi (body mass index) were not reported.Dosage regimens: novopen 4: novorapid penfill: current condition: diabetes (type and duration not reported).Concomitant products included - lantus (insulin glargine).On an unknown date patient suffered from hyperglycemia and was hospitalized (duration not reported) due to novopen 4 issue (did not inject insulin) as on adjusting the dose counter on the target dose and pressing the dose button, the dose counter didn't move without injecting insulin.Batch numbers: novopen 4: unknown.Novorapid penfill: asku.Action taken to novorapid penfill was not reported.The outcome for the event "suffered from hyperglycemia due to her novopen 4 issue(hyperglycemia)" was not reported.The outcome for the event "novopen 4 did not inject insulin(device failure)" was not reported.

Event Description

Case description: investigational result product name novopen® 4, batch number : not reported.No investigation was possible, because neither sample nor batch number was available.Product name novorapid penfill , batch number : not reported.No investigation was possible, because neither sample nor batch number was available.Since last submission the case has been updated with the following; investigation result added imdrf code added relevant fields updated in eu/ca tab narrative updated accordingly.Final manufacturer's comment: 18-mar-2024: the suspected device novopen 4 has not been returned to novo nordisk for evaluation.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 novorapid.H3 continued: evaluation summary product name novopen® 4, batch number : not reported.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: 18901362
• MDR Text Key: 337619483
• Report Number: 9681821-2024-00041
• 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: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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: LANTUS (INSULIN GLARGINE).
• Patient Outcome(s): Hospitalization
• Patient Sex: Female