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

Model Number N/A

Device Problems Loose or Intermittent Connection (1371); Improper Flow or Infusion (2954)

Patient Problem Hyperglycemia (1905)

Event Date 03/01/2023

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas).Patient´s blood glucose was 648mg/dl [blood glucose increased].Plunger of the novopen 4 pen is loose [device loosening].Preventing the medication from being dispensed [drug delivery system issue].Case description: study id: 1852-e-pharma novodia.Study description: trial title: to support the patient in the beginning of treatment with novo nordisk products for diabetes mellitus and obesity.The patient is instructed on how to use, transport and store the products, and receives orientation by phone, site or in person by a nurse.Patient's height: 159 cm.Patient's weight: 65 kg.Patient's bmi: 25.71100830.This serious solicited report from brazil was reported by a consumer as "patient´s blood glucose was 648mg/dl(blood glucose increased)" beginning on (b)(6) 2023 , "plunger of the novopen 4 pen is loose(device component loose)" beginning on (b)(6)2023 , "preventing the medication from being dispensed(drug delivery system issue)" wbeginning on (b)(6) 2023 and concerned a 64 years old female patient who was treated with novopen 4 (insulin delivery device) from unknown start date for "type 2 diabetes", human insulin (insulin human) (dose, frequency & route used- 30 iu, qd) from unknown start date and ongoing for "type 2 diabetes", current condition: type 2 diabetes (1995), hypertension(diagnosed about 5 years ago), insomnia.Concomitant medications included - clonazepam, losartan.Type 2 diabetes (1995), hypertension(diagnosed about 5 years ago), insomnia treatment medication: regular insulin (non codable) the patient informs that she acquired the novopen4 in 2013 and since then she only buys the medicine refill to connect to the pen and carry out her applications.On an unspecified date in (b)(6) 2023 (patient does not remember the exact day) when trying to carry out the application, the pen was defective, the plunger of the novopen 4 pen was loose, preventing the medication from being dispensed and it was not possible to carry out the application.The patient experienced feeling malaise for not using the medication.The patient reports that a few hours later her vision started to get blurry and when checking blood glucose(blood glucose) it was 648 mg/dl, so patient immediately decided to go to the emergency room.When she arrived at the emergency room, physician prescribed regular insulin (she does not remember the dosage) and she stayed for a period of time under observation and was discharged on the same day at around 01:00 am at dawn.The patient was unable to inform the exact day that she sought the emergency room or the exams(laboratory test) she underwent.The patient also informed that due to the problem with her pen, she was going to the public medical center close to her residence every day, with her medical prescription and novolin medicine refill in hand so that the unit nurse can apply the medicine through a syringe.Patient adds that there was a significant decrease in blood glucose levels, but informs that it was not fully controlled (she did not report her current blood glucose levels).The needles were not reused.The needle was not kept threaded into the pen.Batch numbers: novopen 4: cug0200.Human insulin: requested; action taken to human insulin was reported as no change.The outcome for the event "patient´s blood glucose was 648mg/dl(blood glucose increased)" was not yet recovered.The outcome for the event "plunger of the novopen 4 pen is loose(device component loose)" was not reported.The outcome for the event "preventing the medication from being dispensed(drug delivery system issue)" was not reported.Reporter's causality (novopen 4) - patient´s blood glucose was 648mg/dl(blood glucose increased) : probable.Plunger of the novopen 4 pen is loose(device component loose) : unknown.Preventing the medication from being dispensed(drug delivery system issue) : unknown.Company's causality (novopen 4) - patient´s blood glucose was 648mg/dl(blood glucose increased) : possible.Plunger of the novopen 4 pen is loose(device component loose) : possible.Preventing the medication from being dispensed(drug delivery system issue) : possible.Reporter's causality (human insulin) - patient´s blood glucose was 648mg/dl(blood glucose increased) : probable.Plunger of the novopen 4 pen is loose(device component loose) : unknown.Preventing the medication from being dispensed(drug delivery system issue) : unknown.Company's causality (human insulin) - patient´s blood glucose was 648mg/dl(blood glucose increased) : possible.Plunger of the novopen 4 pen is loose(device component loose) : possible.Preventing the medication from being dispensed(drug delivery system issue) : possible.

Event Description

Case description: on (b)(6) 2023, an amendment was performed.-since last submission the following information as been amended, where the significant ird should be kept as (b)(6) 2023 instead of (b)(6) 2023, the batch number of novolin n has been updated to unknown.-the batch number for novolin n remains as unknown, as this batch number reported in ccglow is novopen 4's batch number.Rsvh.

Event Description

Case description: this serious solicited report from brazil was reported by a consumer as "patient´s blood glucose was 648mg/dl(blood glucose increased)" beginning on mar-2023 , "plunger of the novopen 4 pen is loose(device component loose)" beginning on mar-2023 , "preventing the medication from being dispensed(drug delivery system issue)" beginning on mar-2023 and concerned a 64 years old female patient who was treated with novopen 4 (insulin delivery device) from unknown start date for "type 2 diabetes", , human insulin (insulin human) (dose, frequency & route used- 60 iu, qd(30u/in the morning and 30u/in the evening)) from 1995 and ongoing for "type 2 diabetes".Current condition: type 2 diabetes (1995)(28 years), hypertension(diagnosed about 28 years ago)(1995), depression(a long time ago).Batch numbers: human insulin :cugu200 investigational result : suspect product name : novopen® 4 batch number :cug0200 the number of complaints on the batch was evaluated and relevant actions were taken.The product was not returned for examination.Suspect product :novolin® n penfill batch number :unknown no investigation was possible, because neither sample nor batch number was available.If possible, please forward the reported product(s) for further investigations.Since last submission the case has been updated with the following: medical history was updated.Batch number for the suspect novolin n was added investigation results added.Imdrf codes added (b,c,d,g) relevant fields updated in eu/ca tab narrative updated accordingly.References included: reference type: e2b company number reference id#: (b)(4) reference notes: reference type: mw 3500a mfr.Rpt.# reference id#: (b)(4) reference notes: medwatch 3500a mfr.Report number final manufacturer's comment: 19-jul-2023: the suspected device has not been returned to novo nordisk and batch number is also unavailable.Thus, batch trend analysis or reference sample analysis could not be performed.No conclusion is reached.H3 continued: evaluation summary suspect product name : novopen® 4 batch number :cug0200 the number of complaints on the batch was evaluated and relevant actions were taken.The product was not returned for examination.

• 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: 17134589
• MDR Text Key: 317226509
• Report Number: 9681821-2023-00084
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• Reporter Country Code: BR
• PMA/PMN Number: 20-986
• 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,Followup,Followup
• Report Date: 05/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/08/2018
• Device Model Number: N/A
• Device Catalogue Number: 185490
• Device Lot Number: CUG0200
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2013
• 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: CLONAZEPAM (CLONAZEPAM) ONGOING.; LOSARTAN (LOSARTAN) ONGOING.
• Patient Outcome(s): Other
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 65 KG