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

Model Number N/A

Device Problem No Flow (2991)

Patient Problem Hyperglycemia (1905)

Event Type  Injury  

Event Description

[preferred term] (related symptoms if any separated by commas).High blood sugar [blood glucose increased].No insulin came out when pressing the dose button [device failure].Pen did not worked, had to borrow insulin from someone else [prescription drug used without a prescription].Case description: this serious spontaneous case from norway was reported by a health care professional nos as "high blood sugar (blood sugar increased)" with an unspecified onset date, "no insulin came out when pressing the dose button (device failure)" with an unspecified onset date, "pen did not worked, had to borrow insulin from someone else(prescription drug used from another patient)" with an unspecified onset date, and concerned a female patient (born in the year 1967) who was treated with novopen 6 (insulin delivery device) from unknown start date for "product used for unknown indication".Patient's height, weight and body mass index was not reported.Medical history was not provided.On an unknown date, patient found out that the pen did not work - no insulin came out when pressing the dose button.As a consequence patient experienced very high blood sugar (around 30mmol/l) and had to borrow insulin from someone else.Batch numbers: novopen 6: lvg5b84-1.The outcome for the event "high blood sugar (blood sugar increased)" was unknown.The outcome for the event "no insulin came out when pressing the dose button (device failure)" was unknown.The outcome for the event "pen did not worked, had to borrow insulin from someone else (prescription drug used from another patient)" was not reported.Event onset date is not reported in the case.However, the incident dates are captured to ensure the mir form is generated."this report is for a foreign device that is assessed as "similar" to us marketed novopen echo".

• 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: 18578220
• MDR Text Key: 333661398
• Report Number: 9681821-2024-00018
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K123766
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 08/31/2023
• Device Model Number: N/A
• Device Lot Number: LVG5B84-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2021
• 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
• Patient Sex: Female