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

Model Number N/A

Device Problems Mechanical Jam (2983); Failure to Eject (4010)

Patient Problems Hyperglycemia (1905); Diabetic Ketoacidosis (2364)

Event Date 07/01/2021

Event Type  Injury  

Event Description

High level of acetone in blood [blood ketone body increased], hyperglycaemia [hyperglycaemia], novopen4 didn't push insulin [device malfunction], actrapid was not resuspended before use [failure to suspend medication].Case description: study id: (b)(6).Study description: trial title: main objective of the programme is to help patients to understand their diabetes and maintain normal life through qualified educators who offer simple and practical information directly to the patients and also, train patients on how to use their insulin devices and needles etc.The patient's height, weight and body mass index was not reported.This serious solicited report from egypt was reported by a consumer as "high level of acetone in blood(acetone high)" beginning on (b)(6) 2021, "hyperglycaemia(hyperglycaemia)" beginning on (b)(6) 2021, "novopen4 didn't push insulin(device malfunction)" beginning on (b)(6) 2021, "actrapid was not resuspended before use(failure to suspend medication)" with an unspecified onset date and concerned a (b)(6) male patient who was treated with novopen 4 (insulin delivery device) from unknown start date for "diabetes mellitus", actrapid penfill (insulin human) solution for injection, 100 iu/ml (dose, frequency & route used-3 doses/meal, unknown, regimen # 2- 13-14iu/meal after discharge ongoing 3.0 ml unknown) from unknown start date and ongoing for "diabetes mellitus".Current condition: diabetes mellitus (type and duration not reported).Concomitant medications included - tresiba flextouch u100(insulin degludec 100 iu/ml solution for injection, 100 iu/ml).On an unspecified date in (b)(6) 2021, novopen4 did not push insulin which led to hyperglycaemia and high level of acetone in blood so the patient was hospitalized for 3 -4 days.It was reported that the patient reused the needle for 1 or 2 days and the needle was left attached to the pen in between injections.Actrapid penfill was not re-suspended before use.The suspected novopen4 was replaced.Batch numbers: novopen 4: fvg8045.Actrapid penfill: asku; asku.Action taken novopen 4 was not reported.Action taken to actrapid penfill was not reported.The outcome for the event "high level of acetone in blood(acetone high)" was recovered.The outcome for the event "hyperglycaemia(hyperglycaemia)" was recovered.The outcome for the event "novopen4 didn't push insulin(device malfunction)" was not reported.The outcome for the event "actrapid was not resuspended before use(failure to suspend medication)" was not reported.Reporter's causality (novopen 4) - high level of acetone in blood(acetone high): probable.Hyperglycaemia(hyperglycaemia): probable.Novopen4 didn't push insulin(device malfunction): probable.Actrapid was not resuspended before use(failure to suspend medication): unknown.Company's causality (novopen 4) - high level of acetone in blood(acetone high): possible.Hyperglycaemia(hyperglycaemia): possible.Novopen4 didn't push insulin(device malfunction): possible.Actrapid was not resuspended before use(failure to suspend medication): possible.Reporter's causality (actrapid penfill) - high level of acetone in blood(acetone high): unknown.Hyperglycaemia(hyperglycaemia): unknown.Novopen4 didn't push insulin(device malfunction): unknown.Actrapid was not resuspended before use(failure to suspend medication): unknown.Company's causality (actrapid penfill) - high level of acetone in blood(acetone high): possible.Hyperglycaemia(hyperglycaemia): possible.Novopen4 didn't push insulin(device malfunction): possible.Actrapid was not resuspended before use(failure to suspend medication): possible.Preliminary manufacturer's comment: 12-oct-2021: the suspected device novopen 4 has not been returned to novo nordisk for evaluation.No conclusion is reached.

Event Description

Case description: investigation result: product name novopen 4 batch number: fvg8045.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 dose accuracy was measured by weighing using a random cartridge.The product was found to be normal.The results were found to comply with specifications.During examination of the product, no irregularities related to the complaint were detected.Product name: actrapid penfill batch number: unknown.No investigation was possible, because neither sample nor batch number was available.Since last submission, the case has been updated with the following: correction of imdrf code annex d.From d14 to d13.Final manufacturer's comment: 03-dec-2021: the suspected device (novopen 4) has been returned to novo nordisk for evaluation.Upon investigation, device was found to be falsified device.However, device was found to work as specified.No device problem found.No abnormalities relating to the observed problem were found in the reference sample analysis.The batch documentation has been reviewed and found to be normal.Since no faults were found on the returned device novopen 4 and only very limited information regarding the patients handling of the suspected device is reported in the case, it is not possible to elucidate a clear root cause for the experienced adverse event of hyperglycaemia and its complications.Events are listed.This single case report is not considered to change the current knowledge of the safety profile of actrapid penfill.H3 continued: evaluation summary: product name novopen 4 batch number: fvg8045.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 dose accuracy was measured by weighing using a random cartridge.The product was found to be normal.The results were found to comply with specifications.During examination of the product, no irregularities related to the complaint were detected.

• 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: 12654959
• MDR Text Key: 283845643
• Report Number: 9681821-2021-00066
• 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,Study,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/05/2021
• Device Model Number: N/A
• Device Catalogue Number: 185490
• Device Lot Number: FVG8045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2021
• Date Manufacturer Received: 11/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2016
• 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: TRESIBA FLEXTOUCH U100 (INSULIN DEGLUDEC 100 IU/ML
• Patient Outcome(s): Hospitalization
• Patient Age: 13 YR
• Patient Sex: Male