MAUDE Adverse Event Report: NOVO NORDISK A/S NOVOPEN 5; INSULIN DELIVERY DEVICE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas).The patient was hospitalized.[hospitalisation].Case description: this serious spontaneous case from china was reported by a consumer as "at present, the patient was hospitalized.The hospitalization reason was unknown.(hospitalisation)" with an unspecified onset date, and concerned a 30 months old male patient who was treated with novopen 5 (insulin delivery device) from unknown start date for "type 1 diabetes mellitus", novorapid penfill (insulin aspart) (dose, frequency & route used-unk) from unknown start date for "type 1 diabetes mellitus".Patient's weight, height and bmi (body mass index) were not reported.Current condition: type 1 diabetes mellitus(duration not reported) on an unknown date, patient was hospitalized.The novopen was suspected.The reporter did not compliant that the hospitalization was due to novopen and the reason for hospitalization was unknown.It was reported that patient current condition was stable.Batch number of novopen 5 and novorapid penfill were not reported.Action taken to novopen 5 was not reported.Action taken to novorapid penfill was not reported.The outcome for the event "at present, the patient was hospitalized.The hospitalization reason was unknown.(hospitalisation)" was not recovered.Final manufacturer's comment: (b)(6) 2024: the case was initially submitted as serious incident on a conservative basis, with a limited information on technical complaint or malfunction with novopen 5, leading to serious clinical event (hospitalization).However, upon follow-up with reporter, it was confirmed that, event hospitalization was not due to novopen 5.The allegation towards the suspected device ruled out.The case will be submitted as non-reportable final incident report.Company comment: hospitalization is assessed as unlisted event according to the novo nordisk current ccds in novorapid penfill.Relevant information on clinical events due to technical complaint or malfunction with novopen 5, leading to hospitalization and suspected device investigations are unavailable for complete causality assessment.Hospitalization is an outcome of adverse event, not an event per se.This single case report is not considered to change the current knowledge of the safety profile of novorapid penfill."this report is for a foreign device that is assessed as "similar" to us marketed novopen echo".

• Brand Name: NOVOPEN 5
• Type of Device: INSULIN DELIVERY DEVICE
• Manufacturer (Section D): NOVO NORDISK A/S; bagsvaerd,, ; 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: 18604847
• MDR Text Key: 334024651
• Report Number: 9681821-2024-00022
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: K123766
• 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: 01/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/05/2024
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 30 MO
• Patient Sex: Male