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 Problems Hyperglycemia (1905); Hypoglycemia (1912)

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas) the patient was hospitalized to regulate blood glucose.[blood glucose abnormal] novopen 4 could be pushed.No medication liquid came out.[device failure] case description: this serious spontaneous case from china was reported by a consumer as "the patient was hospitalized to regulate blood glucose.(blood glucose abnormal)" with an unspecified onset date, "novopen 4 could be pushed.No medication liquid came out.(device failure)" with an unspecified onset date, and concerned a (age not reported) male patient who was treated with novopen 4 (insulin delivery device) from unknown start date for "type 2 diabetes mellitus", novomix 30 penfill (insulin aspart, insulin aspart protamine) (dose, frequency & route used- 28 iu, qd (14 u in the morning and 14 u in the evening)) from unknown start date for "type 2 diabetes mellitus".Patient's height, weight and body mass index was not reported dosage regimens: novopen 4: novomix 30 penfill: current condition: type 2 diabetes mellitus.(for over 10 years(the patient did not remember the specific year when the disease was diagnosed) concomitant products included - atorvastatin on an unknown date, the novopen 4 could be pushed.No medication liquid came out, and the patient was hospitalized to regulate blood glucose for 7 days(patient did not remember the specific dates) on an unknown date, the patient called the hotline and the hotline guided the handling, the rubber plunger of the penfill was close to the top of the piston rod.The medication liquid came out normally after the needle was installed.The patient accepted that and was trained on the use of the product.The patient did not suspect the product quality.The malfunction was removed successfully.Batch numbers: novopen 4 and novomix 30 penfill: were requested action taken to novopen 4 was not reported.Action taken to novomix 30 penfill was reported as product discontinued due to ae.The outcome for the event "the patient was hospitalized to regulate blood glucose.(blood glucose abnormal)" was not reported.On 05-feb-2024 the outcome for the event "novopen 4 could be pushed.No medication liquid came out.(device failure)" was recovered.

• 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: 18747292
• MDR Text Key: 335870952
• Report Number: 9681821-2024-00035
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: 20-986N/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
• Report Date: 02/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2024
• 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: 02/05/2024
• 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
• Treatment: ATORVASTATIN (ATORVASTATIN)
• Patient Outcome(s): Hospitalization
• Patient Sex: Male