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

Model Number N/A

Device Problems Defective Component (2292); Detachment of Device or Device Component (2907)

Patient Problem Diabetic Ketoacidosis (2364)

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas) suffered from acidosis and hospitalized for 5 days [acidosis] the penfill holder was broken [device breakage] pen might not inject the exact dose/wasn't administrating the dose probably [incorrect dose administered by device] pressing of the button for injection is not normal [device malfunction] case description: this serious spontaneous case from egypt was reported by a consumer as "suffered from acidosis and hospitalized for 5 days(acidosis)" with an unspecified onset date, "the penfill holder was broken(device component detached)" with an unspecified onset date, "pen might not inject the exact dose/wasn't administrating the dose probably(incorrect dose administered by device)" with an unspecified onset date, "pressing of the button for injection is not normal(device component malfunction)" 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", patient height, weight and body mass index (bmi) were not reported dosage regimens: novopen 4: medical history was not provided.On an unknown date novopen 4 might not inject the exact dose as the pressing of the button for injection was not normal.The penfill holder was broken so patient wasn't administrating the dose probably and had acidosis and was hospitalized for 5 days (hospitalization dates were not reported) batch number of novopen 4: bug0787 the outcome for the event "suffered from acidosis and hospitalized for 5 days(acidosis)" was not reported.The outcome for the event "the penfill holder was broken(device component detached)" was not reported.The outcome for the event "pen might not inject the exact dose/wasn't administrating the dose probably(incorrect dose administered by device)" was not reported.The outcome for the event "pressing of the button for injection is not normal(device component malfunction)" was not reported.

Event Description

Case description: investigation result: novopen 4, batch number: bug0787 the number of complaints on the batch was evaluated and, when applicable, relevant actions were taken.The product was not returned for examination.Final manufacturer's comment: 08-mar-2024: the suspected device novopen 4 has not been returned to novo nordisk for evaluation.No abnormalities relating to the observed problem were found in the reference sample analysis.The batch documentation has been reviewed and found to be normal.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.Considering the nature of events, acidosis could be related to diabetic ketoacidosis which is a known complication of chronic diabetes mellitus.H3 continued: evaluation summary: novopen 4, batch number: bug0787.The number of complaints on the batch was evaluated and, when applicable, relevant actions were taken.The product was not returned for examination.

• 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: 18658927
• MDR Text Key: 334751293
• Report Number: 9681821-2024-00025
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: 20-986N/A
• 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: 01/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2024
• 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: BUG0787
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/01/2024
• 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
• Patient Outcome(s): Other; Hospitalization
• Patient Sex: Female