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

Model Number N/A

Device Problems Inaccurate Delivery (2339); Infusion or Flow Problem (2964); Unintended Movement (3026)

Patient Problem Hypoglycemia (1912)

Event Date 10/01/2018

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas): severe hypoglycaemia [hypoglycaemia].Hypoglycaemia and patient took 1 hour to get back to consciousness [hypoglycaemic unconsciousness].Pen is not delivering correct units [incorrect dose administered by device] it operates in jerks [device issue].Case description: this serious spontaneous case from (b)(6) was reported by a consumer as "severe hypoglycaemia" with an unspecified onset date, "hypoglycaemia and patient took 1 hour to get back to consciousness" with an unspecified onset date, "pen is not delivering correct units" with an unspecified onset date, "it operates in jerks" with an unspecified onset date, and concerned a female patient who was treated with novopen 4 (insulin delivery device) from unknown start date due to "device therapy".Patient's height, weight and body mass index were not reported.Medical history included type 1 diabetes mellitus (b)(6).On an unknown date patient experienced severe hypoglycaemia during use of novopen 4.It was reported that the emergency doctor needed 1 hour to get patient back to consciousness.It was also reported that pen was not delivering correct units and it operates in jerks.Batch number available.The outcome for the event "severe hypoglycaemia" was not reported.The outcome for the event "hypoglycaemia and patient took 1 hour to get back to consciousness" was not reported.The outcome for the event "pen is not delivering correct units" was not reported.The outcome for the event "it operates in jerks" was not reported.

Event Description

Severe hypoglycaemia [hypoglycaemia].Hypoglycaemia and patient took 1 hour to get back to consciousness [hypoglycaemic unconsciousness].Pen is not delivering correct units [incorrect dose administered by device].It operates in jerks, the units are difficult to dial plus correct to dial, it is like a cogwheel [device issue].Use of dialling clicks to estimate the dose of the insulin [wrong technique in device usage process].Case description: this serious spontaneous case from germany was reported by a consumer as "severe hypoglycaemia" beginning on oct-2018, "hypoglycaemia and patient took 1 hour to get back to consciousness" beginning on oct-2018, "pen is not delivering correct units" beginning on oct-2018, "it operates in jerks, the units are difficult to dial plus correct to dial, it is like a cogwheel" beginning on oct-2018, "use of dialling clicks to estimate the dose of the insulin" beginning on unspecifed date, and concerned a 30 years old female patient who was treated with novopen 4 (insulin delivery device) from unknown start date to mar-2019 due to "type 1 diabetes mellitus", patient's height: 174 cm, patient's weight: 55 kg, patient's bmi: 18.1660.Concomitant products included - novorapid (insulin aspart) solution for injection, 100 u/ml.On an unspecified date in oct-2018, the patient experienced severe hypoglycaemia during use of novopen 4.It was reported that once the emergency doctor needed 1 hour to get patient back to consciousness.On an unspecified date in oct-2018, the pen was not delivering correct units and it operates in jerks.The units were difficult to dial and correct to dial, it was like a cogwheel.Due to not setting correct units there was too much insulin which resulted in severe hypoglycaemia and patient was hospitalized in intensive care unit.It was reported that the patient was using dialing clicks to estimate the dose of insulin and became unsure of the number of units delivered.The patient measured blood glucose before injecting additional units.It was reported that insulin in use was stored at room temperature 20 - 25 degree celsius and there was no change in diet or physical activity of the patient.The patient was trained by a hcp (health care professional) in the use of novopen 4.Action taken to novopen 4 was product discontinued due to ae (adverse event).The outcome for the event "severe hypoglycaemia" was not yet recovered.The outcome for the event "hypoglycaemia and patient took 1 hour to get back to consciousness" was not reported.The outcome for the event "pen is not delivering correct units" was not reported.The outcome for the event "it operates in jerks, the units are difficult to dial plus correct to dial, it is like a cogwheel" was not reported.The outcome for the event "use of dialling clicks to estimate the dose of the insulin" was not reported.Investigational results: product: novopen 4.Batch number: aug1069.Visual and functional examinations 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 force required to depress the release-button was measured.The result was within acceptable limits.The dose accuracy was measured by weighing using a random penfill cartridge.The results were found to comply with specifications.The device was disassembled to examine internal parts.Foreign matter was observed inside the pen mechanism and under the dose button.The top of the dose button cannot rotate as normal this will give an increase dose force.Confirmed dose button may operate in jerks.Foreign dry matter observed on internal or external pen parts e.G.Dust, dirt or dried stains after a liquid.The observed problem is not related to any novo nordisk processes.The observed fault is a result of accidental damage during use of the device.Since last submission case was updated with the following: event verbatim updated to "it operates in jerks, the units are difficult to dial plus correct to dial, it is like a cogwheel" from "it operates in jerks" additional event of "use of dialling clicks to estimate the dose of the insulin" added onset date of events "severe hypoglycaemia", "hypoglycaemia and patient took 1 hour to get back to consciousness", ""pen is not delivering correct units" and "it operates in jerks, the units are difficult to dial plus correct to dial, it is like a cogwheel" was updated as oct-2018.Seriousness criteria of hospitalization added for the event of "severe hypoglycaemia" outcome for event of "severe hypoglycaemia" updated to "not yet recovered" device codes updated.Reporter's causality updated as probable for the events of "severe hypoglycaemia", "it operates in jerks, the units are difficult to dial plus correct to dial, it is like a cogwheel" and "pen is not delivering correct units".Action taken to novopen 4 updated as product discontinued due to ae and stop date updated as mar-2019.Indication of novopen 4 updated as "type 1 diabetes mellitus".Laboratory data updated.Patient's age, height, weight and body mass index updated.Novorapid added as concomitant medication.Investigation result updated.Manufacturer comment updated.Narrative updated accordingly.Manufacturer comment: 17-apr-2019: one suspected novopen 4 was returned to novo nordisk a/s for investigation.The investigation revealed that there was foreign matter inside the pen mechanism and under the dose button.The top of the dose button cannot rotate as normal this will give an increase dose force.Foreign dry matter observed on internal or external pen parts e.G.Dust, dirt or dried stains after a liquid.The observed problem is not related to any novo nordisk processes.The observed fault is a result of accidental damage during use of the device.Device evaluated by mfr: continued: evaluation summary: product: novopen 4.Batch number: aug1069.Visual and functional examinations 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 force required to depress the release-button was measured.The result was within acceptable limits.The dose accuracy was measured by weighing using a random penfill cartridge.The results were found to comply with specifications.The device was disassembled to examine internal parts.Foreign matter was observed inside the pen mechanism and under the dose button.The top of the dose button cannot rotate as normal this will give an increase dose force.Confirmed dose button may operate in jerks.Foreign dry matter observed on internal or external pen parts e.G.Dust, dirt or dried stains after a liquid.The observed problem is not related to any novo nordisk processes.The observed fault is a result of accidental damage during use of the device.

• Brand Name: NOVOPEN 4
• Type of Device: INSULIN DELIVERY DEVICE
• Manufacturer (Section D): NOVO NORDISK A/S, MEDICAL SYSTEMS; hilleroed, ; DA
• MDR Report Key: 8597036
• MDR Text Key: 144672407
• Report Number: 9681821-2019-00027
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: 20-986
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 03/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/01/2016
• Device Model Number: N/A
• Device Catalogue Number: 185490
• Device Lot Number: AUG1069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2019
• Date Manufacturer Received: 04/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 1) NOVORAPID (INSULIN ASPART)
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 30 YR
• Patient Weight: 55