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

Model Number N/A

Device Problems Break (1069); Improper Flow or Infusion (2954)

Patient Problem Hyperglycemia (1905)

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas).Hyperglycemia [hyperglycaemia] pen's cap is broken [device breakage] pen does not inject the insulin in one shot, but release the insulin drop by drop [device delivery system issue].Case description: this serious spontaneous case from egypt was reported by a consumer as "hyperglycemia(hyperglycemia)" with an unspecified onset date, "pen's cap is broken(device breakage)" with an unspecified onset date, "pen does not inject the insulin in one shot, but release the insulin drop by drop(device delivery system improper flow)" with an unspecified onset date, and concerned a 113 months old male patient who was treated with novopen (insulin delivery device) from unknown start date and ongoing for "type 1 diabetes mellitus", novorapid penfill (insulin aspart) (dose, frequency & route used- 20 iu, qd (7 iu -7 iu and 6 iu before main meal), started 6 years ago, subcutaneous) from unknown start date and ongoing for "type 1 diabetes mellitus", patient's weight: 45 kg.The patient's height and body mass index (bmi) were not reported.Dosage regimens: novopen: novorapid penfill: not reported.Current condition: type 1 diabetes mellitus.(duration: from 6 years ago since he was 3 years old).Concomitant products included - lantus(insulin glargine).On an unknown date, patient's novopen's cap was broken and the pen did not inject the insulin in one shot, but released the insulin drop by drop resulting in hyperglycemia with blood glucose (blood glucose) values of 400-500 mg/dl.The blood glucose levels returned to normal once syringe was used for injection.On an unknown date, patient's last measured hba1c was 10% -3 months ago.Batch numbers: novopen:: requested.Novorapid penfill: mr7dh74.Action taken to novorapid penfill was not reported.Acton taken to novopen was not reported.The outcome for the event "hyperglycemia(hyperglycemia)" was recovered.The outcome for the event "pen's cap is broken(device breakage)" was not reported.The outcome for the event "pen does not inject the insulin in one shot, but release the insulin drop by drop(device delivery system improper flow)" was not reported.Event onset date is not reported in the case.However the incident dates are captured to ensure mir form is generated.Company comment: hyperglycaemia is assessed as listed event according to the novo nordisk current ccds in novorapid penfill.Since the blood glucose returned to normal after using with a syringe, malfunction with drug delivery device (novopen) could be the cause for hyperglycaemia.However, the suspected device has not been returned to novo nordisk for evaluation.This single case report is not considered to change the current knowledge of the safety profile of novorapid penfill.Reporter comment: the reporter mentioned that she is using the novorapid penfill with pen related to sanofi which had the problem, so she was asked to return back to them and i confirmed that novorapid penfills are used with novopen.

Event Description

Case description: investigation results: name: novopen, batch number: unknown.No investigation was possible, because neither sample nor batch number was available.Name: novorapid penfill 3 ml 100iu/ml, batch number: mr7dh74.The number of complaints on the batch was evaluated and, when applicable, relevant actions were taken.The product was not returned for examination.A reference sample was examined macroscopically 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.Since last submission, case was updated with the following: investigation results updated.Imdrf ( b,c,d and g) codes updated.Narrative has been updated accordingly.Final manufacturer's comment: 12-mar-2024: the specific name of device is unknown.The defective device has not been returned to novo nordisk for evaluation.Batch number of the device unavailable despite repeated efforts to find the same.No batch trend analysis or reference sample analysis performed.With the available limited information regarding the handling of the suspected device, it is not possible to identify a clear root cause in relation to functionality of novopen.Patient's underlying medical condition of type 1 diabetes mellitus is a risk factor for the development of hyperglycaemia.H3 continued: evaluation summary.Novopen, batch number: unknown.No investigation was possible, because neither sample nor batch number was available.

• Brand Name: NOVOPEN
• 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: 18550745
• MDR Text Key: 333314924
• Report Number: 9681821-2024-00017
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• Reporter Country Code: EG
• PMA/PMN Number: K861686
• 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
• Report Date: 01/02/2024

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 Model Number: N/A
• Device Catalogue Number: 185230
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/02/2024
• Initial Date FDA Received: 01/22/2024
• Supplement Dates Manufacturer Received: 03/07/2024
• Supplement Dates FDA Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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: LANTUS (INSULIN GLARGINE) ONGOING
• Patient Outcome(s): Other
• Patient Age: 9 YR
• Patient Sex: Male
• Patient Weight: 45 KG