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

Model Number N/A

Device Problem No Flow (2991)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

(related symptoms if any separated by commas).Hospitalized at icu [hospitalisation].Non-injection of insulin by novopen 4 [device failure].Case description: this serious spontaneous case from egypt was reported by a patient family member or friend as "non-injection of insulin by novopen 4 (device failure)" with an unspecified onset date, "hospitalized at icu (hospitalization)" with an unspecified onset date, and concerned a female patient who was treated with novopen 4 (insulin delivery device) and insulin (unspecified) from unknown start date for "device therapy." patient's height, weight and bmi (body mass index) were not reported.Medical history was not provided.On an unknown date, the patient was hospitalized at icu due to non-injection of insulin by the novopen 4.Hospitalization details not specified.Batch number of novopen was requested.The outcome for the event "non-injection of insulin by novopen 4 (device failure)" was not reported.The outcome for the event "hospitalized at icu (hospitalization)" was not reported.

• 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: 18451146
• MDR Text Key: 332259489
• Report Number: 9681821-2024-00005
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: 20-986
• 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: 12/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: N/A
• Device Catalogue Number: 185490
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/22/2024
• 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): Hospitalization
• Patient Sex: Female