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

Model Number N/A

Device Problem Inaccurate Delivery (2339)

Patient Problem Hypoglycemia (1912)

Event Date 11/09/2021

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas).Hypoglycaemic episode blood glucose level 2.1 mmol/l [hypoglycaemia].Device malfunction [device malfunction].Case description: this serious spontaneous case from (b)(6) was reported by a consumer as "hypoglycaemic episode blood glucose level 2.1 mmol/l (hypoglycaemic episode)" beginning on (b)(6) 2021, "device malfunction (device malfunction)" with an unspecified onset date, and concerned a female patient who was treated with novopen 4 (insulin delivery device) from unknown start date for "type 2 diabetes mellitus", , novofine (needle) from unknown start date for "type 2 diabetes mellitus", mixtard 30/70 penfill (insulin human) suspension for injection, 100 iu/ml (dose, frequency & route used- 16 iu, qd, unknown and regimen #2- 18 iu, qd, unknown) from unknown start date and ongoing for "type 2 diabetes mellitus", concomitant products included - metformin.Patient's height, weight and body mass index (bmi) was not reported.Current condition: type 2 diabetes mellitus (duration was not reported).On an unspecified date in (b)(6) 2021, the patient's blood glucose was 9.8 mmol/l.On (b)(6) 2021, patient's blood glucose level was 2.1 mmol/l.It was reported that patient was given lemonade and toast to bring blood glucose levels back up.Patient was given the choice to go to hospital or straight to the local doctor.Patient chose to go to doctor and over there patient's blood glucose level was 2.9 mmol/l.The physician advised the patient to get a new novopen 4 and the patient obliged.Patient had her diabetes medications changed in the past weeks.Her mixtard 30/70 dose was changed from 16 units last week to 18 units this week and she discontinued her metformin tablets.Batch numbers of novopen 4 and novofine was requested.Action taken to novopen 4 was reported as product discontinued due to ae.Action taken to novofine was reported as no change.Action taken to mixtard 30/70 penfill was reported as no change.On (b)(6) 2021 the outcome for the event "hypoglycaemic episode blood glucose level 2.1 mmol/l (hypoglycaemic episode)" was recovered.The outcome for the event "device malfunction (device malfunction)" was not reported.

Event Description

Case description: batch number for mixtard 30/70 penfill: lr78j81.Investigational result: name: mixtard 30/70 penfill 3ml, batch number: lr78j81.A reference sample was examined macroscopically, microscopically and analysed chemically.The reference sample was found to be normal.The results were found to comply with specifications.During investigation no irregularities related to the complaint was detected on a reference/reserve sample of the batch in question.Name: novofine, 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.Name: novopen 4, 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 case was updated with the following: - inv result updated.-b, c, d and g codes updated.- 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 reference type: mw 3500a mfr.Rpt.# reference id#: (b)(4).Reference notes: medwatch 3500a mfr.Report number final manufacturer's comment: (b)(6) 2022: the suspected device novofine needle and novopen 4 have not been returned to novo nordisk and batch number is also unavailable.Batch trend analysis or reference device analysis not performed.With very limited information regarding handling of the suspected device reported in the case, it is not possible to elucidate a clear root cause for the experienced adverse event of hypoglycaemia.However, increase in the dose of mixtard from (b)(4) might have resulted in occurrence of hypoglycaemia in the patient.Company comment: hypoglycaemia is assessed as listed event according to the novo nordisk current ccds in mixtard 30/70 penfill.Increase in the dose of mixtard from (b)(4) might have resulted in occurrence of hypoglycaemia in the patient.This single case report is not considered to change the current knowledge of the safety profile of mixtard 30/70 penfill.H3 continued: evaluation summary: name: novopen 4, 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.

Event Description

Case description: batch numbers of novopen 4: hvgp048-1 and batch number of novofine was requested.Batch number for mixtard 30/70 penfill: lr78j81.The suspect novopen 4 has been returned to novo nordisk for investigation.Once the investigation is completed, a final report will be submitted.Since last submission case was updated with the following: - batch number of novopen 4 updated.- device available for evaluation updated for novopen 4.- device addendum , eu/ca tabs updated for novopen 4.- qc comment for for novopen 4 deleted.- narrative updated accordingly.Final manufacturer's comment: 10-feb-2022: the suspected device novopen echo has been returned to novo nordisk for evaluation.Investigation is ongoing.04-jan-2022: the suspected product novopen 4 examination is not possible because of unavailability of batch number or returned sample.No conclusion is reached.Insulin dose adjustment such as mixtard 30/70 from (b)(4) could have resulted in hypoglycaemia.

Event Description

Case description: patient's height, weight and body mass index (bmi) were not reported.Investigational result: name: mixtard 30/70 penfill 3ml, batch number: lr78j81 a reference sample was examined macroscopically, microscopically and analysed chemically.The reference sample was found to be normal.The results were found to comply with specifications.During investigation no irregularities related to the complaint was detected on a reference/reserve sample of the batch in question.Name: novofine, 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.Name :novopen 4 , batch number :hvgp048-1.Visual examination and functional testing were performed.The device was tested with a random cartridge and a novo nordisk needle was mounted.During testing it was possible to deliver preparation from the cartridge.A visual examination of the returned product was performed.The dose accuracy was measured by weighing using a random cartridge.The results were found to comply with specifications.During examination of the product, no irregularities related to the complaint were detected.Since last submission case was updated with the following: investigations for novopen 4 updated.Narrative updated.Eu/ca and device addedndum tabs updated for novopen 4.Final manufacturer's comment: 18- mar-2022: the returned device was found to be functioning normally and comply with set specifications.10-feb-2022: the suspected device novopen 4 has been returned to novo nordisk for evaluation.Investigation is ongoing.05-jan-2022: the suspected device novofine needle have not been returned to novo nordisk and batch number is also unavailable.Batch trend analysis or reference device analysis not performed.With very limited information regarding handling of the suspected device reported in the case, it is not possible to elucidate a clear root cause for the experienced adverse event of hypoglycaemia.However, increase in the dose of mixtard from 16 to 18 units might have resulted in occurrence of hypoglycaemia in the patient.Company comment: hypoglycaemia is assessed as listed event according to the novo nordisk current ccds in mixtard 30/70 penfill.Increase in the dose of mixtard from 16 to 18 units might have resulted in occurrence of hypoglycaemia in the patient.This single case report is not considered to change the current knowledge of the safety profile of mixtard 30/70 penfill.H3 continued: evaluation summary name :novopen, batch number : hvgp048-1.Visual examination and functional testing were performed.The device was tested with a random cartridge and a novo nordisk needle was mounted.During testing it was possible to deliver preparation from the cartridge.A visual examination of the returned product was performed.The dose accuracy was measured by weighing using a random cartridge.The results were found to comply with specifications.During examination of the product, no irregularities related to the complaint were detected.

• 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: 12907795
• MDR Text Key: 286938262
• Report Number: 9681821-2021-00078
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• Reporter Country Code: AS
• 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,Followup,Followup
• Report Date: 11/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 185490
• Device Lot Number: HVGP048-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2021
• Initial Date Manufacturer Received: 11/09/2021
• Initial Date FDA Received: 12/01/2021
• Supplement Dates Manufacturer Received: 12/28/2021; 11/15/2021; 03/14/2022
• Supplement Dates FDA Received: 01/11/2022; 02/14/2022; 04/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2018
• 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: METFORMIN (METFORMIN).
• Patient Outcome(s): Other
• Patient Sex: Female