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

Model Number N/A

Device Problem No Flow (2991)

Patient Problem Hyperglycemia (1905)

Event Date 04/05/2019

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas).High ketosis (ketosis).Hyperglycaemia (hyperglycaemia).Insulin does not always come out (device failure).Case description: this serious spontaneous case from france was reported by a pharmacist as "high ketosis" beginning on (b)(6) 2019, "hyperglycaemia" beginning on (b)(6) 2019, "insulin does not always come out" beginning on (b)(6) 2019 and concerned an adult female patient, born in the year (b)(6) who was treated with tresiba penfill 100 u/ml (insulin degludec) from (b)(6) 2019 due to "type 1 diabetes mellitus", dose and frequency 16 iu, qd (16 units on the morning), novopen 4 (insulin delivery device) from unknown start date due to "type 1 diabetes mellitus".Patient's height: 160 cm.Patient's weight and body mass index not reported.Medical history included type 1 diabetes mellitus (duration not reported).On (b)(6) 2019, patient had hyperglycaemia (high blood glucose: value not reported) and high ketosis (high ketones: value not reported), almost went to hospital after 3 days of injection with the new pen.It was reported that insulin did not come out.It was reported that the rubber plug was in contact with the piston and the needle was placed straight but the pen did not work every time.Patient checked the functioning of the pen with the nurse.Patient used another pen as treatment received for the event.Batch number available.Action taken to tresiba penfill 100 u/ml was reported as product discontinued due to adverse event (ae).Action taken to novopen 4 was reported as not reported.On (b)(6) 2019 the outcome for the event "high ketosis" was recovered.On (b)(6) 2019 the outcome for the event "hyperglycaemia" was recovered.The outcome for the event "insulin does not always come out" was not reported.Investigational results: product name tresiba® penfill® 100 u/ml 3 ml.Batch number: hs66194.The product was not returned for examination.No conclusion can be made without the sample or a valid batch number.Product name: novopen® 4.Batch number: hvgl161-5.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 dose accuracy was measured by weighing using a random cartridge.The results were found to comply with specifications.During examination/test of the product it has not been possible to detect any irregularities.The product was found to be normal.Manufacturer's comment: 13-may-2019: since no faults were found on the returned device (novopen 4) and only very limited information regarding the patient's handling of suspected device is reported in the case, it is not possible to elucidate a clear root cause for the experienced adverse event and thus not possible to find similar incidents to the one reported in argus case (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 penfill.Reporter comment: the causal role was assessed as probable.The reporter suspected a quality defect because the pen functioned randomly.The reporter assessed the case as medically significant.Evaluation summary: product name: novopen® 4.Batch number: hvgl161-5.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 dose accuracy was measured by weighing using a random cartridge.The results were found to comply with specifications.During examination/test of the product it has not been possible to detect any irregularities.The product was found to be normal.

• 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
• Manufacturer Contact: p.o. box 846; plainsboro, NJ 08536 ; 8007276500
• MDR Report Key: 8631488
• MDR Text Key: 145758301
• Report Number: 9681821-2019-00036
• 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: foreign,health professional
• Type of Report: Initial
• Report Date: 04/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 185490
• Device Lot Number: HVGL161-5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2019
• Date Manufacturer Received: 04/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other