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

Model Number N/A

Device Problems Failure to Deliver (2338); No Flow (2991)

Patient Problem Ischemia Stroke (4418)

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas) the patient experienced cerebral infarction [cerebral infarction] no medication could be pushed out.[device failure] case description: this serious spontaneous case from china was reported by a consumer as "the patient experienced cerebral infarction(cerebral infarction)" with an unspecified onset date, "no medication could be pushed out.(device failure)" with an unspecified onset date, and concerned a patient who was treated with novopen (insulin delivery device) from unknown start date for "device therapy", dosage regimens: novopen: not reported medical history was not provided.On an unknown date, no medication could be pushed out by novopen.On an unknown date, the patient experienced cerebral infarction.Batch number of novopen was not obtainable.Action taken to novopen was not reported.The outcome for the event "the patient experienced cerebral infarction(cerebral infarction)" was not reported.The outcome for the event "no medication could be pushed out.(device failure)" was not reported.No further information available.

Event Description

Case description: since last submission, the following has been updated: -final report date has been updated.

• Brand Name: NOVOPEN
• 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: 18649962
• MDR Text Key: 334639894
• Report Number: 9681821-2024-00023
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K861686N/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: 01/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: N/A
• Device Catalogue Number: 185230
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: No
• 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