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

Model Number N/A

Device Problem Failure to Deliver (2338)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912)

Event Date 04/01/2023

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas).Hyperglycemia bgl was 500mg/dl at night) [hyperglycaemia].Np4 did not inject insulin [device failure].Needle left attached in the pen during the day [product storage error].Hypoglycemia(60 mg/dl) [hypoglycaemia].Patient had another dose by syringe [extra dose administered].Case description: this serious spontaneous case from egypt was reported by a consumer as "hyperglycemia bgl was 500mg/dl at night)(hyperglycemia)" beginning on (b)(6) 2023, "np4 did not inject insulin(device failure)" beginning on (b)(6) 2023, "needle left attached in the pen during the day(device stored with needle attached)" beginning on (b)(6) 2023, "hypoglycemia(60 mg/dl)(hypoglycaemia)" beginning on (b)(6) 2023, "patient had another dose by syringe(extra dose administered)" beginning on (b)(6) 2023, and concerned a child male patient who was treated with novopen 4 (insulin delivery device) from unknown start date for "type 1 diabetes mellitus", actrapid penfill (insulin human) (dose, frequency & route used- 33 iu, qd(12u morning-11u at launch- 10u night)) from 2016 and ongoing for "type 1 diabetes mellitus".Patient's height: 85 cm.Patient's weight: 35 kg.Patient's bmi: 48.44290660.Dosage regimens: novopen 4: actrapid penfill: ??-???-2016 to not reported (dosage regimen ongoing); current condition: type 1 diabetes mellitus (since 2016, from 7 years ago).Concomitant products included - lantus(insulin glargine).On an unknown date of (b)(6) 2023, five days ago patient had hyperglycemia the blood glucose was reached 500 mg/dl at night and he took lantus (his long-acting insulin) and took correction dose from actrapid.It was reported that he was recovered after he took his doses by syringe.Patient complained np4 didn't inject insulin.So in the morning his blood glucose was 60mg/dl (hypoglycemia) and became normal after taking his breakfast.The causality is unlike for actrapid, but it was happened because she gives the patient another dose by syringe.Patient recovered two days ago.Patient hba1c (glycosylated hemoglobin) was 7.4% last month, rbs(random blood glucose) today was 180mg/dl fbs(fasting blood sugar) 200 mg/dl, ppbs(post prandial blood sugar) 220 mg/dl.Patient training was offered and during it the mechanical part and the piston rod moved normally after adjusting the dose counter to 60 u and press the dose button (twice) adding the penfill, to make sure that the piston rod head touch the pen fill rubber by adjusting the dose counter to 60 u and pressing the dose button without needle , the counter returned back to 0u he was informed that this penfill is used one, so he was asked to get a new penfill and to repeat the last step , the counter stopped at 58 u he was asked to return the counter back to zero by adding a new needle, the pen injected insulin (4u) by confirmation the pen is stored outside the refrigerator.It was reported that the needle left attached in the pen during the day and needle was used for only one day for 3 injections.There was no change in diet or exercise.Batch numbers: novopen 4: hvgl647.Actrapid penfill: mr7cx20.Action taken to novopen 4 was reported as product discontinued.Action taken to actrapid penfill was not reported.On (b)(6) 2023 the outcome for the event "hyperglycemia bgl was 500mg/dl at night)(hyperglycemia)" was recovered.The outcome for the event "np4 did not inject insulin(device failure)" was not reported.The outcome for the event "needle left attached in the pen during the day(device stored with needle attached)" was not reported.On (b)(6) 2023 the outcome for the event "hypoglycemia(60 mg/dl)(hypoglycaemia)" was recovered.The outcome for the event "patient had another dose by syringe(extra dose administered)" was not reported.

Event Description

Case description: investigation result.Name: actrapid® penfill® 3 ml 100iu/ml, batch number: mr7cx20 the product was not returned for examination.Name: novopen® 4, batch number: hvgl647: the product was not returned for examination.Since last submission following information was added: investigation result added.Imdrf code added.Relevant fields updated in eu/ca tab.Narrative updated accordingly.Final manufacturer's comment: 13-jun-2023: the suspected device (novopen 4) has not been returned to novo nordisk a/s for the investigation.Batch number of devices is not available despite repeated efforts find the same.Batch trend analysis or reference sample analysis was not 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 4.Product storage error such as storing the device with needle attached between injections can affect the functionality of novopen 4.Patient's underlying medical condition of type 1 diabetes mellitus is a confounding factor for hyperglycaemia.Events are listed.This single case report is not considered to change the current knowledge of the safety of actrapid penfill.H3 continued: evaluation summary.Name: novopen® 4, batch number: hvgl647: 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: 16824039
• MDR Text Key: 314100217
• Report Number: 9681821-2023-00062
• 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: 04/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 07/03/2023
• Device Model Number: N/A
• Device Catalogue Number: 185490
• Device Lot Number: HVGL647
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/04/2018
• 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: LANTUS (INSULIN GLARGINE).
• Patient Outcome(s): Other
• Patient Sex: Male
• Patient Weight: 35 KG