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

Model Number N/A

Device Problems Failure to Deliver (2338); Mechanics Altered (2984); No Flow (2991)

Patient Problems Hyperglycemia (1905); Missed Dose (2561)

Event Date 08/16/2018

Event Type  Injury  

Event Description

Blood glucose level was 398 mg/dl,902 mg/dl,898 mg/dl [blood glucose increased].The device had not been functioning, the insulin did not come out no matter how many times he attempted;the black part inside novopen 4 spun around and did not move forward,parts depressing the rubber piston doesn't contact to the rubber piston [device failure].Not been able to give an today's injection [drug dose omission by device].Haemoglobin a1c was 18% [glycosylated haemoglobin increased].Case description: this serious spontaneous case from japan was reported by a consumer as "blood glucose level was 398 mg/dl,902 mg/dl,898 mg/dl" beginning on (b)(6) 2018, "the device had not been functioning, the insulin did not come out no matter how many times he attempted;the black part inside novopen 4 spun around and did not move forward,parts depressing the rubber piston doesn't contact to the rubber piston" beginning on (b)(6) 2018, "not been able to give an today's injection" beginning on (b)(6) 2018, "haemoglobin a1c was 18%" beginning in 2018, and concerned a male patient who was treated with novopen 4 (insulin delivery device) from unknown start date due to "diabetes mellitus", , tresiba chu penfill (insulin degludec) from unknown start date and ongoing due to "diabetes mellitus", (regimen #1 dose and frequency unknown, regimen #2 dose and frequency 10 u, qd) medical history included diabetes mellitus (type and duration not reported).The patient had been using tresiba with novopen 4 for three years.On an unknown date in 2018 (reported as previous month), hba1c(glycosylated haemoglobin) level was 18% it was reported that since (b)(6) 2018 night , the device had not been functioning.After using tresiba penfill for six times, insulin stopped being delivered.The black part inside novopen 4 spun around and did not move forward.It was reported that the parts depressing the rubber piston did not contact to the rubber piston.On (b)(6) 2018, the morning of the fifth day of using novopen 4,and tresiba penfill at 10 units per time, insulin was not delivered after attaching a needle.It was reported that the insulin did not come out no matter how many times he attempted.Blood glucose level was 398 mg/dl.Patient was instructed by a pharmacist of the hospital where he was seen to store only the insulin cartridge in a refrigerator after injection.Patient insisted he made no mistake in handling.On (b)(6) 2018, the patient had not been able to give the injection.Patient monitored blood glucose level at 898 mg/dl.Patient had monitored blood glucose level just before the reporting using onetouch pen, which was 902 mg/dl.Patient developed numbness.Action taken to novopen 4 was not reported.Action taken to tresiba chu penfill was not reported.The outcome for the event "blood glucose level was 398 mg/dl,902 mg/dl,898 mg/dl" was not reported.The outcome for the event "the device had not been functioning, the insulin did not come out no matter how many times he attempted;the black part inside novopen 4 spun around and did not move forward,parts depressing the rubber piston doesn't contact to the rubber piston" was not reported.The outcome for the event "not been able to give an today's injection" was not reported.The outcome for the event "haemoglobin a1c was 18%" was not reported.No further information available.Company comment: the reported events are listed.This single case report is not considered to change the current knowledge of the safety profile of tresiba.

Event Description

Case description: investigation results: product name: novopen 4.Batch number: unknown.No investigation was possible, because neither sample nor batch number was available.Product name: tresiba chu penfill u100.Batch number: unknown.No investigation was possible, because neither sample nor batch number was available.Since last submission, the following was updated: investigational results updated.Manufacturer's comment updated.Narrative updated accordingly.Manufacturer's comment/company comment: 03-oct-2018: as the device novopen 4 has not been returned to novo nordisk a/s for investigation and very limited information regarding the handling of suspected device is available, it is not possible to identify a clear root-cause of the experienced adverse event and thus find similar incidents to the one reported in (b)(4).The reported events are listed.This single case report is not considered to change the current knowledge of the safety profile of tresiba.Evaluation summary: product name: novopen 4.Batch number: unknown.No investigation was possible, because neither sample nor batch number was available.

• Brand Name: NOVOPEN 4
• Type of Device: INSULIN DELIVERY DEVICE
• Manufacturer (Section D): NOVO NORDISK A/S, MEDICAL SYSTEMS; hilleroed, ; DA
• MDR Report Key: 7873688
• MDR Text Key: 120161607
• Report Number: 9681821-2018-00057
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• 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: 08/17/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 185490
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other