MAUDE Adverse Event Report: NOVO NORDISK A/S, MEDICAL SYSTEMS NOVOPEN 3; INSULIN DELIVERY DEVICE

Model Number N/A

Device Problems Defective Component (2292); Defective Device (2588)

Patient Problem Hyperglycemia (1905)

Event Date 04/08/2024

Event Type  Injury  

Event Description

(related symptoms if any separated by commas).Sugar levels 500 mg/dl and 692 mg/dl(this morning) [blood glucose increased].Novopen 3 not working properly, the medicine did not come out [device failure].Case description: study id: 831713-novocare for diabetes.Study description: trial title: the main objective of this patient support programme is to provide education, information and training for patients with diabetes mellitus (type 1, type 2 and diabetes in pregnancy), who have already been prescribed by their treating health care professional (hcp) with novo nordisk (nn) products of insulin, liraglutide 0.6-1.8mg for type 2 diabetes and glucagen.Patients shall be provided with full education, including the technical use and handling of nn devices (pens and needles) with an objective to be supported during their first steps in their treatment and to have an improved diabetes control and quality of life.Patients with type 2 diabetes mellitus, who have already been prescribed by their treating hcp with once weekly glp-1 inhibitor semaglutide (ozempic), with a purpose to enhance the education of the patients on their disease, through pen training, to improve diabetes control and patient's quality of life, through nutritional advice and to support treatment adherence and compliance on with their prescribed therapy.Finally, under the scope of the program the provider must undertake the provision pharmaceutical compliance and any pharmacovigilance service.This serious solicited report from greece was reported by a patient as "sugar levels 500 mg/dl and 692 mg/dl(this morning)(blood sugar increased)" beginning on (b)(6) 2024 , "novopen 3 not working properly, the medicine did not come out(device failure)" with an unspecified onset date and concerned a 78 years old female patient who was treated with novopen 3 (insulin delivery device) from unknown start date for "diabetes type 2", penmix 30 penfill (dose, frequency & route used-77 iu, qd(14iu in the morning,18 iu in the evening, 35 iu at night), subcutaneous) (insulin human, insulin isophane) from 1982 and ongoing for "diabetes type 2".Dosage regimens: novopen 3: penmix 30 penfill: -1982 to not reported (dosage regimen ongoing); current condition: diabetes type 2(duration not reported) on (b)(6) 2024, patient's blood sugar(blood glucose) was found to be 500mg/dl at noon and that night patient had 259mg/dl.On an unknown date, this morning patient had 692 mg/dl.Novopen 3 is not working properly.In particular, patient mentioned that in the last few days the button was pressed very easily, but the medicine did not come out.Batch number of novopen 3 and penmix 30 penfill was not reported action taken to penmix 30 penfill was reported as no change.The outcome for the event "sugar levels 500 mg/dl and 692 mg/dl(this morning)(blood sugar increased)" was recovering/resolving.The outcome for the event "novopen 3 not working properly, the medicine did not come out(device failure)" was not reported.Reporter's causality (novopen 3) - sugar levels 500 mg/dl and 692 mg/dl(this morning)(blood sugar increased) : probable novopen 3 not working properly, the medicine did not come out(device failure) : unknown company's causality (novopen 3) - sugar levels 500 mg/dl and 692 mg/dl(this morning)(blood sugar increased) : possible novopen 3 not working properly, the medicine did not come out(device failure) : possible reporter's causality (penmix 30 penfill) - sugar levels 500 mg/dl and 692 mg/dl(this morning)(blood sugar increased) : unlikely novopen 3 not working properly, the medicine did not come out(device failure) : unknown company's causality (penmix 30 penfill) - sugar levels 500 mg/dl and 692 mg/dl(this morning)(blood sugar increased) : possible novopen 3 not working properly, the medicine did not come out(device failure) : possible preliminary manufacturer's comment: 17-apr-2024: the suspected device novopen 3 and suspected product penmix 30 penfill has not been returned to novo nordisk for evaluation.No conclusion reached.Event abated after use stopped or dose reduced? doesn't apply event reappeared after reintroduction? doesn't apply.

• Brand Name: NOVOPEN 3
• 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: 19141738
• MDR Text Key: 340567668
• Report Number: 9681821-2024-00072
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• Reporter Country Code: GR
• PMA/PMN Number: 19-938
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 185290
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/09/2024
• 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
• Patient Outcome(s): Other
• Patient Age: 78 YR
• Patient Sex: Female