MAUDE Adverse Event Report: NOVO NORDISK A/S NOVOPEN 6; INSULIN DELIVERY DEVICE

Model Number N/A

Device Problems Improper or Incorrect Procedure or Method (2017); Inaccurate Delivery (2339); Device Handling Problem (3265)

Patient Problems Hypoglycemia (1912); Coma (2417)

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas).Hypoglycemic coma [hypoglycaemic coma].Patient was in emergency room/ hospital during use of novopen 6 because he injected twice the amount [extra dose administered].Patient use the dialling clicks to estimate the dose of the insulin [wrong technique in device usage process].Case description: this serious spontaneous case from germany was reported by a pharmacist as "hypoglycemic coma(hypoglycemic coma)" with an unspecified onset date, "patient was in emergency room/ hospital during use of novopen 6 because he injected twice the amount(extra dose administered)" with an unspecified onset date, "patient use the dialling clicks to estimate the dose of the insulin(wrong technique in device usage process)" with an unspecified onset date, and concerned a 660 months old male patient who was treated with novopen 6 (insulin delivery device) from unknown start date for "device therapy", patient's height: 175 cm.Patient's weight: 80 kg.Patient's bmi: 26.122449.Current condition: type 2 diabetes mellitus (since 2000).Concomitant products included - fiasp(insulin aspart) solution for injection, 100 iu/ml, bisoprolol, xarelto(rivaroxaban), indapamide;perindopril ongoing, rosuvastatin treatment included - glucose.On an unknown date, the patient experienced hypoglycemic coma as patient injected twice the amount during use of novopen 6.From (b)(6) 2023, the patient was in emergency room/ hospital and was treated with glucose.On (b)(6) 2023, the patient was discharged from hospital.It was reported that the product was administered to patient by the son and use the dialing clicks to estimate the dose of the insulin.There was no change in diet or the physical exercise.Patient stored the insulin in use at room temperature 20 - 25 °c.Patient do not attach and keep the needle to device and did not reuse the needle.Uses by attaching the needle to the pen in a 180 degree angle.Re suspends the product before use.Age of the device was 2 months.Patient did not drop the pen and there was no leakage of the insulin from the device.Did not recently change from another novopen to the current novopen batch numbers: novopen 6: lvg5g39.The outcome for the event "hypoglycemic coma(hypoglycemic coma)" was unknown.The outcome for the event "patient was in emergency room/ hospital during use of novopen 6 because he injected twice the amount(extra dose administered)" was not reported.The outcome for the event "patient use the dialling clicks to estimate the dose of the insulin(wrong technique in device usage process)" was not reported.References included: reference type: e2b company number.Reference id#: de-novoprod-1062957.Reference notes: "this report is for a foreign device that is assessed as "similar" to us marketed novopen echo".

Event Description

Case description: since last submission following information has been updated -expected final report date updated in eu/ca device tab since investigation results and imdrf codes of novopen 6 are still under investigation.-narrative updated.This report is for a foreign device that is assessed as "similar" to us marketed novopen echo.

Event Description

Case description: investigation results: name: novopen 6, batch number: lvg5g39.A visual examination of the returned product was performed.The electronic register was checked.No remarks.Visual examination and functional testing were performed.No remarks.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.The dose accuracy was measured by weighing using a random cartridge.The results were found to comply with specifications.The returned device has been examined, found to function normally.When using a new needle and cartridge there was no problem in using the device.During examination of the product, no irregularities related to the complaint were detected.Since last submission the case has been updated with the following: investigation results updated.Annex b, c, d, and g codes updated.Eu/ca tab updated with relevant fields.Narrative has been updated accordingly.References included: reference type: e2b company number.Reference id#: (b)(4).Final manufacturer's comment: on 31-jul-2023: the suspected device novopen 6 has been returned to novo nordisk for evaluation.Upon investigation, device was found to be working as intended, no abnormalities detected.No abnormalities relating to the observed problem were found in the reference sample analysis.The batch documentation has been reviewed and found to be normal.Since no faults were found on the returned device novopen 6 and only very limited information regarding the patients handling of the suspected device is reported in the case, it is not possible to elucidate a clear root cause for the experienced adverse events.H3 continued: evaluation summary: name: novopen 6, batch number: lvg5g39.A visual examination of the returned product was performed.The electronic register was checked.No remarks.Visual examination and functional testing were performed.No remarks.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.The dose accuracy was measured by weighing using a random cartridge.The results were found to comply with specifications.The returned device has been examined, found to function normally.When using a new needle and cartridge there was no problem in using the device.During examination of the product, no irregularities related to the complaint were detected.

Event Description

Case description: on 06-jun-2023, an amendment was performed.Since last submission, the following information has been amended initially the case was submitted with manufacturer's comment " product handling error such as storing the device with needle attached, between needles", now the case will be amended by removing this comment.

• Brand Name: NOVOPEN 6
• Type of Device: INSULIN DELIVERY DEVICE
• Manufacturer (Section D): NOVO NORDISK A/S; bagsvaerd,, ; DA
• Manufacturer (Section G): NOVO NORDISK A/S; krogshoejvej 55; bagsvaerd,, 2880 ; DA 2880
• Manufacturer Contact: p.o. box 846; plainsboro, NJ 08536 ; 8007276500
• MDR Report Key: 17018057
• MDR Text Key: 316288443
• Report Number: 9681821-2023-00076
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K123766
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/28/2023
• Device Model Number: N/A
• Device Lot Number: LVG5G39
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2021
• 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: BISOPROLOL (BISOPROLOL) ONGOING; FIASP (INSULIN ASPART); INDAPAMIDE,PERINDOPRIL (INDAPAMIDE,PERINDOPRIL); ROSUVASTATIN (ROSUVASTATIN); XARELTO (RIVAROXABAN)
• Patient Outcome(s): Hospitalization
• Patient Age: 660 MO
• Patient Sex: Male
• Patient Weight: 80 KG