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

Model Number N/A

Device Problems Mechanical Jam (2983); Device Handling Problem (3265)

Patient Problems Hyperglycemia (1905); Injection Site Reaction (4562)

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas) ppbgl was 660mg/dl [hyperglycaemia].Pen is stiff [device mechanical issue].Pen didn' inject insulin [device failure].Re-fill the mixtard penfill by insulinagypt vial insulin by a syringe to use it by the pen [intentional product misuse].Hypoglycaemia [hypoglycaemia].Sometimes blood appeared at the injection sites [injection site haemorrhage].Swelling at the injection sites [injection site swelling].Needle attached to the pen in between injections [product storage error].Patient used dialling clicks to estimate the dose of the product [wrong technique in product usage process].Case description: this serious spontaneous case from egypt was reported by a consumer as "ppbgl was 660mg/dl(postprandial hyperglycaemia)" with an unspecified onset date, "pen is stiff(device mechanical jam)" with an unspecified onset date, "pen didn' inject insulin(device failure)" with an unspecified onset date, "re-fill the mixtard penfill by insulinagypt vial insulin by a syringe to use it by the pen(intentional product misuse)" with an unspecified onset date, "hypoglycaemia(hypoglycaemia)" with an unspecified onset date, "sometimes blood appeared at the injection sites(injection site bleeding)" with an unspecified onset date, "swelling at the injection sites(injection site swelling)" with an unspecified onset date, "needle attached to the pen in between injections(device stored with needle attached)" with an unspecified onset date, "patient used dialling clicks to estimate the dose of the product (wrong injection technique)" with an unspecified onset date and concerned a 709 months old male 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-90 iu, qd (60-30), regimen #2: 60 iu, qd (during fasting (ramadan hegry month),before meal) ) from unknown start date for "drug use for unknown indication".Current condition: diabetes mellitus, nephritis, hypertension.On an unknown date, patient re-filled the mixtard penfill by insulinagypt vial insulin by a syringe to use it by the pen.It was reported that, patient suffered from swelling at the injection sites (sometimes blood appeared) and the fbgl (fasting blood glucose level) was 550mg/dl and ppbgl (post prandial blood glucose level) was 660 mg/dl.The patient in general reuse insulin.For one week and was advised to change it regularly.Patient's hba1c was 13.8%, decreased to 7% during using mixtard and increased again to more than 12 % from 2 months ago (before using any product).It was reported that the patient experienced a problem with the device as the pen was stiff and didn't' inject insulin.Injection of the suspected product sometimes into a skin area with lumps but aggravated with using the novopen 4 not appear during syringes.The needle was attached to the pen in between injections.Before the experienced event occurred.The cartridge holder didn't detach from the pen body accidentally or intentional and after assembly he checked the insulin flow.The force needed to inject feel different from normal (more difficult) and used dialing clicks to estimate the dose of the product.The patient in general reuse insulin for one week and was advised to change it regularly 6 months ago and stopped one week ago and started using syringes with insulinagypt as he had technical issue with the pen as the pen is stiff and didn't' inject insulin it was reported that 3 days ago suffered from postprandial hyperglycaemia, as he decreased the doses.Lack of efficacy wasn't suspected.As it caused hyperglycaemia and hypoglycaemia as when he directed to hcp to adjust blood glucose level he increased the dose but after that his blood glucose level decreased.Batch numbers: novopen 4: lvg3n82 mixtard penfill: asku, asku action taken to mixtard penfill was reported as product discontinued.The outcome for the event "ppbgl was 660mg/dl(postprandial hyperglycaemia)" was not reported.The outcome for the event "pen is stiff(device mechanical jam)" was not reported.The outcome for the event "pen didn' inject insulin(device failure)" was not reported.The outcome for the event "re-fill the mixtard penfill by insulinagypt vial insulin by a syringe to use it by the pen(intentional product misuse)" was not reported.The outcome for the event "hypoglycaemia(hypoglycaemia)" was not reported.The outcome for the event "sometimes blood appeared at the injection sites(injection site bleeding)" was not yet recovered.The outcome for the event "swelling at the injection sites(injection site swelling)" was not yet recovered.The outcome for the event "needle attached to the pen in between injections(device stored with needle attached)" was not reported.The outcome for the event "patient used dialling clicks to estimate the dose of the product (wrong injection technique)" was not reported.References included: reference type: e2b company number reference id#: (b)(4).Reference notes:.

Event Description

Case description: investigation result novopen® 4, batch number: lvg3n82 the product was not returned for examination.Mixtard penfill - batch unknown no investigation was possible, because neither sample nor batch number was available.Since last submission following information was added: investigation result added imdrf code added narrative updated accordingly.Final manufacturer's comment: 28-apr-2023: the suspected device novopen 4 has not been returned to novo nordisk for evaluation.The batch trend analysis and reference sample examination revealed nothing abnormal.No abnormalities relating to the observed problem were found.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 4.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 novopen® 4, batch number: lvg3n82 the product was not returned for examination.

• 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: 16702117
• MDR Text Key: 312899356
• Report Number: 9681821-2023-00049
• 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,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 185490
• Device Lot Number: LVG3N82
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2021
• 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
• Patient Outcome(s): Other
• Patient Age: 709 MO
• Patient Sex: Male