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

Model Number N/A

Device Problems Improper or Incorrect Procedure or Method (2017); Inaccurate Delivery (2339); Mechanical Jam (2983)

Patient Problem Hyperglycemia (1905)

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas) the patient's bgl was high on the glucometer and above 600 mg/dl on another glucometer [hyperglycaemia] the pen doesn't inject insulin normally due to piston rod movement issue [drug delivery system issue] press the dose button, but the piston rod was sucked inside the mechanical parts (twice) [device mechanical issue] dialling clicks to estimate the dose of the product [wrong technique in device usage process] needle attached to the pen in between injections [product storage error] change the site of injection every 3 days [lack of injection site rotation] case description: this serious spontaneous case from egypt was reported by a consumer as "the patient's bgl was high on the glucometer and above 600 mg/dl on another glucometer(hyperglycemia)" with an unspecified onset date, "the pen doesn't inject insulin normally due to piston rod movement issue(drug delivery system issue)" with an unspecified onset date, "press the dose button, but the piston rod was sucked inside the mechanical parts (twice)(device mechanical jam)" with an unspecified onset date, "dialling clicks to estimate the dose of the product(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, "change the site of injection every 3 days(lack of injection site rotation)" with an unspecified onset date, and concerned a 15 years old female patient who was treated with novopen 4 (insulin delivery device) from unknown start date for "diabetes mellitus type 1", novorapid penfill (insulin aspart) (dose, frequency & route used- uncontrolled diabetes: 20u with lunch, breakfast:8iu; controlled: 10-12 u, subcutaneous) from unknown start date for "diabetes mellitus type 1".Patient's height: 159 cm patient's weight: 40 kg patient's bmi: 15.82215890.Current condition: type 1 diabetes mellitus (from 7 years), stomach pain, thyroid gland.Concomitant products included - lantus(insulin glargine), bepra(rabeprazole sodium), zeourix(non-codable) started from 7 years and still using it and dose 1 tab 50 mg and 1 tab 100 mg per day, insupen needle(non-codable) treatment included - novorapid flexpen(insulin aspart) on an unknown date, there was a problem in patient's daughter novopen 4 (using novorpaid penfills) as the pen didn't inject insulin normally due to piston rod movement issue.The force become more easier as the piston rod was not moving.Due to the technical; complaint on an unknown date, the patient suffered from hyperglycemia from two weeks and blood glucose was high on the glucometer and above 600 mg/dl on another glucometer.It was also reported that pen training was offered and during it, the dose counter moved normally by adjusting it to 60 u and pressed the dose button, but the piston rod was sucked inside the mechanical parts (twice).It was reported that the patient was asked to pull the piston rod out from the mechanical parts manually.Added a new penfill and to make sure that the piston rod head touch the penfill rubber by adjusting the dose counter to 60 u and pressed the dose button without needle, the counter returned back to zero (several times).It was also reported that patient currently uses novorapid flexpen as the patient could not use novorapid penfilll due to the novopen 4 issue.On an unknown date (reported as today morning), the patient's blood glucose was found to be 137mg/dl.Parent was the operator of the device and leaves the needle attached to the pen in between injections.Uses dialing clicks to estimate the dose of the product and changes the site of injection every 3 days.Also changed the needle once daily every 3 injections and attach the needle to the pen in a 180 degree angle.The needle used was insupen needle.Stores the insulin in use at room temperature 20-25 degrees celsius.The patient did not change from another novopen to the current novopen recently.The cartridge holder did not detach from the pen body accidentally or intentional.There was not any injection of the suspected product into a skin area with lumps.There was not any change in diet or exercise batch numbers: novopen 4: evg6149 novorapid penfill: mr7dh74 action taken to novorapid penfill was reported as product discontinued.The outcome for the event "the patient's bgl was high on the glucometer and above 600 mg/dl on another glucometer(hyperglycemia)" was recovered.The outcome for the event "the pen doesn't inject insulin normally due to piston rod movement issue(drug delivery system issue)" was not reported.The outcome for the event "press the dose button, but the piston rod was sucked inside the mechanical parts (twice)(device mechanical jam)" was not reported.The outcome for the event "dialling clicks to estimate the dose of the product(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.The outcome for the event "change the site of injection every 3 days(lack of injection site rotation)" was not reported.References included: reference type: company number reference id#: (b)(4) reference notes:.

Event Description

Investigation result: novopen® 4, batch number: evg6149.The product was not returned for examination.Novorapid® penfill® 3 ml 100iu/ml, batch number: mr7dh74.The product was not returned for examination.Since last submission the case has been updated with the following: investigation result added, imdrf code added, and narrative updated accordingly.Final manufacturer's comment: 24-apr-2023: the suspected device novopen 4 has not been reported to novo nordisk for investigation.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.Incorrect handling of the product such as storing the device with needle attached between injections, product preparation error and using dialling clicks to measure insulin dosage can affect the functionality of devices.Events are listed.This single case report is not considered to change the current knowledge of the safety profile of novorapid penfill.H3 continued: evaluation summary: novopen® 4, batch number: evg6149.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: 16672224
• MDR Text Key: 312600060
• Report Number: 9681821-2023-00044
• 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: 03/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/05/2020
• Device Model Number: N/A
• Device Catalogue Number: 185490
• Device Lot Number: EVG6149
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2015
• 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: BEPRA (RABEPRAZOLE SODIUM) 08/--/2022 TO UNK; LANTUS (INSULIN GLARGINE) ONGOING
• Patient Outcome(s): Other
• Patient Age: 15 YR
• Patient Sex: Female
• Patient Weight: 40 KG