MAUDE Adverse Event Report: NOVO NORDISK A/S NOVOPEN 5; INSULIN DELIVERY DEVICE

Model Number N/A

Device Problems Improper or Incorrect Procedure or Method (2017); Failure to Deliver (2338); Device Handling Problem (3265)

Patient Problem Hyperglycemia (1905)

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas).Blood glucose was high.The post-prandial blood glucose was 20-30 mmol/l [hyperglycaemia].The patient could push the product during use, but no medication came out [device delivery system issue].The patient did not follow the handling instructions [wrong technique in device usage process].Needle attached to the pen in between injections [product storage error].Case description: this serious spontaneous case from china was reported by a consumer as "blood glucose was high.The post-prandial blood glucose was 20-30 mmol/l(postprandial hyperglycaemia)" with an unspecified onset date, "the patient could push the product during use, but no medication came out(failure of delivery by device)" with an unspecified onset date, "the patient did not follow the handling instructions(wrong technique in device usage process)" with an unspecified onset date, "needle attached to the pen in between injections(device stored with needle attached)" with an unspecified onset date, and concerned a 65 years old male patient who was treated with novopen 5 (insulin delivery device) from unknown start date for "device therapy", patient's height: 159 cm.Patient's weight: 75 kg.Patient's bmi: 29.666548.Dosage regimens: novopen 5: current condition: type 2 diabetes mellitus.Concomitant products included - novolin 30r penfill(insulin human) suspension for injection, 100 iu/ml , metformin.On an unspecified date((b)(6) 2023), patient started the to use novopen 5 and could push the product during use, but no medication came out.The patient did not follow the handling instructions.The blood glucose was high, the post-prandial blood glucose was reported as 20-30 mmol/l.The patient thought there was a problem with the pen and requested to replace the pen.The pen was replaced with a new one.Patient reuses the needle some time and leave the needle attached to the pen in between injections.Patient determined the dose by the scale on the novopen.Patient had a possible of change in diet or exercise and did not feel the force needed to inject different from normal.The medication was just shaken between the angle of a and b and stored in refrigerator.Batch numbers: novopen 5: lvg2v22.Action taken to novopen 5 was not reported.The outcome for the event "blood glucose was high.The post-prandial blood glucose was 20-30 mmol/l(postprandial hyperglycaemia)" was not reported.The outcome for the event "the patient could push the product during use, but no medication came out(failure of delivery by device)" was not reported.The outcome for the event "the patient did not follow the handling instructions(wrong technique in device usage process)" was not reported.The outcome for the event "needle attached to the pen in between injections(device stored with needle attached)" was not reported."this report is for a foreign device that is assessed as "similar" to us marketed novopen echo".

Event Description

Case description: since last submission, the case has been updated with the following: eu/ca tab (final report date was updated) on 05-apr-2023, the final report date has been updated since investigation results and imdrf codes of novopen 5 are still under investigation.

Event Description

Case description: investigation results: novopen® 5, batch number: lvg2v22 a visual examination of the returned product was performed.The electronic register was checked.No remarks.Visual examination and functional testing were performed.The returned device was found to function normally.When using a new needle there is no problem in using the device.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, the case has been updated with the following: malfunction updated to no investigation results added.Annex b, d, d, g codes added narrative updated accordingly final manufacturer's comment: 25-may-2023: the suspected device novopen 5 has been returned to novo nordisk and investigation of the device showed that it was working in accordance to specifications.Since no faults were found on the returned device 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 event of hyperglycaemia.However, elderly age of the patient (65 years) , needle reusage and dietary change is a significant confounding factor that could have contributed to hyperglycaemia.This report is for a foreign device that is assessed as "similar" to us marketed novopen echo h3 continued: evaluation summary novopen® 5, batch number: lvg2v22 a visual examination of the returned product was performed.The electronic register was checked.No remarks.Visual examination and functional testing were performed.The returned device was found to function normally.When using a new needle there is no problem in using the device.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 5
• Type of Device: INSULIN DELIVERY DEVICE
• Manufacturer (Section D): NOVO NORDISK A/S; bagsvaerd,, ; 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: 16465633
• MDR Text Key: 310494584
• Report Number: 9681821-2023-00027
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K123766
• 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
• Report Date: 02/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/01/2023
• Device Model Number: N/A
• Device Lot Number: LVG2V22
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2023
• Date Manufacturer Received: 05/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2021
• 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: METFORMIN (METFORMIN); NOVOLIN 30R PENFILL (INSULIN HUMAN)
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 75 KG