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

Model Number N/A

Device Problems Defective Component (2292); Inaccurate Delivery (2339); Device Handling Problem (3265)

Patient Problem Hyperglycemia (1905)

Event Date 08/01/2023

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas).Suffered from hyperglycemia (537 mg/dl ) [hyperglycaemia].Pen injects inaccurate doses [device delivery system issue] lack of efficacy [drug ineffective].The cartridge holder didn't detach from the pen body accidentally or intentional [device malfunction].The parent use the 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].Case description: this serious spontaneous case from egypt was reported by a patient family member or friend as "suffered from hyperglycemia (537 mg/dl )(hyperglycemia)" beginning on (b)(6)2023, "pen injects inaccurate doses(inaccurate delivery by device)" beginning on (b)(6)2023, "lack of efficacy(lack of drug effect)" beginning on (b)(6) 2023, "the cartridge holder didn't detach from the pen body accidentally or intentional(device component malfunction)" beginning on (b)(6) 2023, "the parent use the 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, and concerned a 6 years old male patient who was treated with novopen 4 (insulin delivery device) from unknown start date for "type 1 diabetes mellitus", tresiba penfill (insulin degludec) (14 u, subcutaneous) from (b)(6) 2023 and ongoing for "type 1 diabetes mellitus", patient's height: 135 cm.Patient's weight: 26.5 kg.Patient's bmi: 14.54046640.Dosage regimens: novopen 4: tresiba penfill: (b)(6) 2023 to not reported (dosage regimen ongoing); current condition: type 1 dm (from 2 years), patient did not suffered from any other medical history.Historical drug: tresiba flextouch (since 2 years and 2 months till (b)(6) 2023).Concomitant products included - novorapid penfill(insulin aspart) solution for injection, 100 iu/ml ongoing (since 2 years and 2 months).On an unknown date patient started with novorapid penfill since 2 years and 2 months).On an unspecified date in (b)(6) 2023, the patient started using tresiba penfill with novopen4, stopped using tresiba flextouch and administered the dose (not specific) at 11pm after meal.The patient had a problem with novopen 4 which injected inaccurate doses and the next day at 5am experienced hyperglycemia with random blood glucose level (blood glucose) of 537 mg/dl from 4-5 days.Patient also reported lack of efficacy.It was reported that tresiba was used only for a week.It was also reported that corrective doses of novorapid penfill only 2 iu or 3 iu if rbg was 400 mg/dl or more.The needle was attached to the pen in between injections.The force needed to inject don't feel different from normal.The patient in general reuse the needles (trade name not specified).The parent uses the dialling clicks to estimate the dose of the product.The cartridge holder didn't detach from the pen body accidentally or intentional.The needle attached to the pen in a 180 degree angle (straight on).The insulin stored in use at room temperature 20-25 degrees celsius.Batch numbers: novopen 4: jvgx735.Tresiba penfill: ns6hl10.Action taken to tresiba penfill was not reported.The outcome for the event "suffered from hyperglycemia (537 mg/dl )(hyperglycemia)" was not yet recovered.The outcome for the event "pen injects inaccurate doses(inaccurate delivery by device)" was not reported.The outcome for the event "lack of efficacy(lack of drug effect)" was not reported.The outcome for the event "the cartridge holder didn't detach from the pen body accidentally or intentional(device component malfunction)" was not reported.The outcome for the event "the parent use the 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 recovered.References included: reference type: e2b company number.Reference id#: (b)(4).Reference notes: preliminary manufacturer's comment: (b)(6) 2023: the suspected device novopen 4 has not been returned to novo nordisk for evaluation.No conclusion is reached.

Event Description

Case description: investigational results: name: novopen 4, batch number: jvgx735 visual examination and functional testing were performed.The device was tested with a random cartridge and a novo nordisk needle was mounted.During testing it was possible to deliver preparation from the cartridge.The number of complaints on the batch was evaluated and, when applicable, relevant actions were taken.The pen surface was worn.Scratches or dents in pen surfaces, or wear on printed or engraved figures on the pen surface caused by normal or rough use of the device.The fault has no impact on the mechanical functions of the pen.The piston rod was bent, causing problems when attempting to retract the piston rod into the pen body.The problem was caused by accidental damage after the product has left novo nordisk.The dose accuracy was measured by weighing using a random cartridge.The results were found to comply with specifications.Microscopic examination performed.Glass pieces were observed on several pen parts.Confirmed the crack in the cartridge holder was caused be an external influence.Its look like the edge of the cartridge holder has been forced down in the pen snap connection and damaged by glass pieces most likely from a broken cartridge.And there are also mark after some kind of pull force.The observed problem could not be related to any novo nordisk processes.Confirmed damaged pen parts were observed as a result of the use of a cracked or broken cartridge in the device and/or glass fragment(s) observed in the pen mechanism.The observed problem could not be related to any novo nordisk processes and was a result of accidental damage during use of the device.Confirmed the device has been exposed to exaggerated force during use causing damaged to the cartridge holder name: (b)(6), batch number: ns6hl10.The number of complaints on the batch was evaluated and, when applicable, relevant actions were taken.The product was not returned for examination.Since last submission the case has been updated with following information: invesitigational results were updated.Imdrf codes updated.Narrative updated accordingly.Final manufacturer's comment 10-oct-2023: the suspected device novopen 4 has been returned to novo nordisk for evaluation.Upon preliminary examination, it was found that piston rod was slightly bent, cartridge holder cracked on one side.Scratches or dents in pen surfaces, or wear on printed or engraved figures on the pen surface caused by normal or rough use of the device.The problem is caused by accidental damage after the product has left novo nordisk.The device was tested with a random cartridge and a novo nordisk needle was mounted.During testing it was possible to deliver preparation from the cartridge.On microscopic examination, glass pieces were observed on several pen parts.Damaged pen parts were observed because of the use of a cracked or broken cartridge in the device and/or glass fragment(s) observed in the pen mechanism.The observed problem could not be related to any novo nordisk processes and is a result of accidental damage during use of the device.Continued: evaluation summary.Name: novopen 4, batch number: jvgx735.Visual examination and functional testing were performed.The device was tested with a random cartridge and a novo nordisk needle was mounted.During testing it was possible to deliver preparation from the cartridge.The number of complaints on the batch was evaluated and, when applicable, relevant actions were taken.The pen surface was worn.Scratches or dents in pen surfaces, or wear on printed or engraved figures on the pen surface caused by normal or rough use of the device.The fault has no impact on the mechanical functions of the pen.The piston rod was bent, causing problems when attempting to retract the piston rod into the pen body.The problem was caused by accidental damage after the product has left novo nordisk.The dose accuracy was measured by weighing using a random cartridge.The results were found to comply with specifications.Microscopic examination performed.Glass pieces were observed on several pen parts.Confirmed the crack in the cartridge holder was caused be an external influence.Its look like the edge of the cartridge holder has been forced down in the pen snap connection and damaged by glass pieces most likely from a broken cartridge.And there are also mark after some kind of pull force.The observed problem could not be related to any novo nordisk processes.Confirmed damaged pen parts were observed as a result of the use of a cracked or broken cartridge in the device and/or glass fragment(s) observed in the pen mechanism.The observed problem could not be related to any novo nordisk processes and was a result of accidental damage during use of the device.Confirmed the device has been exposed to exaggerated force during use causing damaged to the cartridge holder.

• 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: 17640079
• MDR Text Key: 322151270
• Report Number: 9681821-2023-00118
• 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: 08/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: N/A
• Device Catalogue Number: 185490
• Device Lot Number: JVGX735
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 10/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/27/2019
• 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: NOVORAPID PENFILL (INSULIN ASPART)
• Patient Outcome(s): Other
• Patient Age: 6 YR
• Patient Sex: Male
• Patient Weight: 26 KG