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

Model Number N/A

Device Problems Device Difficult to Setup or Prepare (1487); Improper or Incorrect Procedure or Method (2017); Inaccurate Delivery (2339)

Patient Problems Hypoglycemia (1912); Loss of consciousness (2418)

Event Type  Injury  

Event Description

Event verbatim: [preferred term] (related symptoms if any separated by commas) patient injected another 40 iu then he felt dizzy and lost his consciousness [hypoglycaemic unconsciousness].Patient injected another 40 iu then he felt dizzy and lost his consciousness [extra dose administered].Novopen didn't inject the dose [device delivery system issue] force needed to inject feel different from normal (e) [device difficult to use].Case description: study id: (b)(6).Study description: trial title: main objective of the programme is to help patients to understand their diabetes and maintain normal life through qualified educators who offer simple and practical information directly to the patients and also, train patients on how to use their insulin devices and needles etc.Patient's height, weight and body mass index (bmi) were not reported.This serious solicited report from egypt was reported by a consumer as "patient injected another 40 iu then he felt dizzy and lost his consciousness(hypoglycemic unconsciousness)" with an unspecified onset date , "patient injected another 40 iu then he felt dizzy and lost his consciousness (extra dose administered)" with an unspecified onset date, "novopen didn't inject the dose(device delivery system issue)" with an unspecified onset date , "force needed to inject feel different from normal (device difficult to use)" with an unspecified onset date and concerned a patient who was treated with novopen 4 (insulin delivery device) from unknown start date for "device therapy", mixtard penfill (insulin human) (dose, frequency & route used-unk, unknown) from unknown start date and ongoing for "diabetes mellitus".Dosage regimens: novopen 4: mixtard penfill: current condition: diabetes mellitus (type and duration not reported), hypertension.On an unknown date patient adjusted novopen 4 on 40 iu and tried to inject the dose but novopen did not inject the dose.On unknown date, patient injected another 40 iu and then patient felt dizzy and lost consciousness.It was reported that, force needed to inject feel different from normal (easier) and patient in general used a new needle or needle didn't attached to the pen in between injections.The cartridge holder didn't detach from the pen body accidentally or intentional.Batch numbers: novopen 4: dvg1840 mixtard penfill: asku; action taken to mixtard penfill was reported as no change.The outcome for the event "patient injected another 40 iu then he felt dizzy and lost his consciousness(hypoglycemic unconsciousness)" was not reported.The outcome for the event "patient injected another 40 iu then he felt dizzy and lost his consciousness(extra dose administered)" was not reported.The outcome for the event "novopen didn't inject the dose(device delivery system issue)" was not reported.The outcome for the event "force needed to inject feel different from normal(device difficult to use)" was not reported.Reporter's causality (novopen 4) - patient injected another 40 iu then he felt dizzy and lost his consciousness.(hypoglycemic unconsciousness) : probable.Patient injected another 40 iu then he felt dizzy and lost his consciousness(extra dose administered) : unknown.Novopen didn't inject the dose(device delivery system issue) : unknown.Force needed to inject feel different from normal(device difficult to use) : unknown.Company's causality (novopen 4) - patient injected another 40 iu then he felt dizzy and lost his consciousness.(hypoglycemic unconsciousness) : possible.Patient injected another 40 iu then he felt dizzy and lost his consciousness(extra dose administered) : possible.Novopen didn't inject the dose(device delivery system issue) : possible.Force needed to inject feel different from normal(device difficult to use) : possible.Reporter's causality (mixtard penfill) - patient injected another 40 iu then he felt dizzy and lost his consciousness.(hypoglycemic unconsciousness) : probable.Patient injected another 40 iu then he felt dizzy and lost his consciousness(extra dose administered) : unknown.Novopen didn't inject the dose(device delivery system issue) : unknown.Force needed to inject feel different from normal(device difficult to use) : unknown.Company's causality (mixtard penfill) - patient injected another 40 iu then he felt dizzy and lost his consciousness.(hypoglycemic unconsciousness) : possible.Patient injected another 40 iu then he felt dizzy and lost his consciousness(extra dose administered) : possible.Novopen didn't inject the dose(device delivery system issue) : possible.Force needed to inject feel different from normal (device difficult to use) : possible.References included: reference type: (b)(4), report duplicate.Reference id #: (b)(4).Reference notes: affiliate reference number.Reference type: (b)(4) company number.Reference id#: (b)(4).Reference notes: (b)(4) company number.

Event Description

Case description: investigational results: suspect: novopen 4, batch: dvg1840.Visual examination and functional testing were performed.It was not possible to investigate the returned sample comprehensively due to the pen condition.Foreign dry matter observed on internal or external pen parts e.G., dust, dirt, or dried stains after a liquid.The observed problem was not related to any novo nordisk processes and it was a result of accidental damage during use of the device.The cartridge holder was damaged in its connection to the mechanical part of the pen.It was not possible to attach the cartridge holder correctly and the device cannot function with a needle and a cartridge attached.The dose accuracy may be affected.The fault was caused by accidental damage during use of the device.Since last submission case has been updated with inv updated, final report checked in eu/ca device tab is non-reportable selected as no device narrative updated narrative updated accordingly.Final manufacturer's comment: (b)(6) 2022: the suspected device novopen 4 has been returned to novo nordisk.Upon visual examination, it was found that both sides of snap end of the cartridge holder are cracked.Dirt/foreign dry matter observed on pen parts.If the user does not detect the fault on the cartridge holder there is a risk that the patient will only receive a partial or no dose at all.In the present case, patient took extra dose resulting in hypoglycaemic unconsciousness.The fault is considered to be handling related.Reported events are listed.This single case report is not considered to change the current knowledge of the safety profile of mixtard penfill.H3 continued: evaluation summary suspect: novopen 4, batch: dvg1840, visual examination and functional testing were performed.It was not possible to investigate the returned sample comprehensively due to the pen condition.Foreign dry matter observed on internal or external pen parts e.G., dust, dirt, or dried stains after a liquid.The observed problem was not related to any novo nordisk processes and it was a result of accidental damage during use of the device.The cartridge holder was damaged in its connection to the mechanical part of the pen.It was not possible to attach the cartridge holder correctly and the device cannot function with a needle and a cartridge attached.The dose accuracy may be affected.The fault was caused by accidental damage during use of the device.

• 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: 13042166
• MDR Text Key: 288289936
• Report Number: 9681821-2021-00094
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• 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,Study,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/25/2019
• Device Model Number: N/A
• Device Catalogue Number: 185490
• Device Lot Number: DVG1840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2021
• Date Manufacturer Received: 12/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/26/2014
• 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