MAUDE Adverse Event Report: NOVO NORDISK A/S NOVOPEN 6; INSULIN DELIVERY DEVICE

Model Number N/A

Device Problem Leak/Splash (1354)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912)

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas) must be hospitalized to control her diabetes [diabetes mellitus inadequate control] leaking silver novopen 6 pen [device leakage] case description: this serious spontaneous case from france was reported by a consumer as "must be hospitalized to control her diabetes(diabetes mellitus inadequate control)" with an unspecified onset date, "leaking silver novopen 6 pen(device leakage)" with an unspecified onset date, and concerned a female patient who was treated with novopen 6 (insulin delivery device) from unknown start date for "device therapy", patient's height, weight and body mass index (bmi) were not reported dosage regimens: novopen 6: current condition: diabetes mellitus (type and duration: not reported) on an unknown date, patient reported about leaking silver novopen 6 pen, product leaked onto her skin.The patient must be hospitalized for a week at the hospital to regulate her diabetes batch numbers: novopen 6: mvg8g77 action taken to novopen 6 was reported as unknown.The outcome for the event "must be hospitalized to control her diabetes(diabetes mellitus inadequate control)" was unknown.The outcome for the event "leaking silver novopen 6 pen(device leakage)" was unknown.Event onset date not reported in the case,.However, incident dates are captured to ensure mir form is generated."this report is for a foreign device that is assessed as "similar" to us marketed novopen echo".

Event Description

Case description: this serious spontaneous case from france was reported by a consumer as "must be hospitalized to control her diabetes(diabetes mellitus inadequate control)" with an unspecified onset date, "leaking silver novopen 6 pen(device leakage)" with an unspecified onset date, and concerned a female patient who was treated with novopen 6 (insulin delivery device) from unknown start date for "device therapy", , tresiba penfill 100 u/ml (insulin degludec) from unknown start date for "drug use for unknown indication", dosage regimens: novopen 6: tresiba penfill 100 u/ml: batch numbers: tresiba penfill 100 u/ml: ns6hv80.Action taken to tresiba penfill 100 u/ml was not reported.Since last submission the following has been updated: expected date of follow- up report was updated.Tresiba was added as suspect, narrative was updated accordingly.References included: reference type: e2b company number.Reference id#: fr-novoprod-1163899.Reference notes: reference type: mw 3500a mfr.Rpt.#.Reference id#: 9681821-2024-00028.Reference notes: medwatch 3500a mfr.Report number."this report is for a foreign device that is assessed as "similar" to us marketed novopen echo".

Event Description

Case description: since last submission the following has been updated: expected date of follow- up report was updated.Narrative was updated accordingly.

• Brand Name: NOVOPEN 6
• Type of Device: INSULIN DELIVERY DEVICE
• Manufacturer (Section D): NOVO NORDISK A/S; bagsvaerd,, ; DA
• Manufacturer (Section G): NOVO NORDISK A/S; krogshoejvej 55; bagsvaerd,, 2880 ; DA 2880
• Manufacturer Contact: p.o. box 846; plainsboro, NJ 08536 ; 8007276500
• MDR Report Key: 18667987
• MDR Text Key: 334901933
• Report Number: 9681821-2024-00028
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• Reporter Country Code: FR
• PMA/PMN Number: K123766N/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,Followup
• Report Date: 01/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 02/16/2024
• Device Model Number: N/A
• Device Lot Number: MVG6L74
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 04/10/2024
• Date Device Manufactured: 02/16/2022
• 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 Sex: Female