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

Model Number N/A

Device Problem Inaccurate Delivery (2339)

Patient Problems Hyperglycemia (1905); Coma (2417)

Event Type  Injury  

Event Description

Novopen 4 didn't inject the accurate dose [incorrect dose administered by device].Hyperglycemia and entered into coma [diabetic hyperglycaemic coma].Fills the syringes from the penfills [wrong technique in product usage process].Case description: study id: (b)(6).Study description: the objective of the programme is to perform outbound calls to the patients who have received samples of novo nordisk (b)(4) products.This is to confirm that they have received the sample, and verify if they have any problems with regard to the product received, or any problem with regard to diabetes.Patient's height: (b)(6).Patient's weight: (b)(6).Patient's bmi: 27.3440.This serious solicited report from (b)(6) was reported by a consumer as "novopen 4 didn't inject the accurate dose" with an unspecified onset date , "hyperglycemia and entered into coma" beginning on (b)(6) 2018 , "fills the syringes from the penfills" with an unspecified onset date and concerned an adolescent male patient (age not reported) who was treated with novopen 4 (insulin delivery device) from unknown start date due to "device therapy" and insulatard penfill hm(ge) 3.0 ml (insulin human) from (b)(6) 2018 and ongoing due to "type 1 diabetes mellitus" (dose and frequency unknown).Medical history included type 1 diabetes mellitus (since (b)(6) years) and didn't suffer from any other diseases.No concomitant medication was taken.On an unknown date patient stopped using novopen 4 didn't inject the accurate dose and the patient's blood glucose level reached to 600 and 700 mg/dl and entered coma.After 15 days of receiving the pen, patient suffered from hyperglycemia and entered coma many times.There were no recent changes in insulin regimen and no lack of efficacy was suspected.It was reported that the patient filled the syringes from the insulatard penfills.Product continued with the same doses.Batch number was not available and was requested.Action taken to insulatard penfill hm(ge) 3.0 ml was not reported.The outcome for the event "novopen 4 didn't inject the accurate dose" was not reported.The outcome for the event "hyperglycemia and entered into coma" was recovered.The outcome for the event "fills the syringes from the penfills" was not reported.Reporter's causality ( novopen 4) - novopen 4 didn't inject the accurate dose: unknown, hyperglycemia and entered into coma: unknown, fills the syringes from the penfills: unknown.Company's causality ( novopen 4) - novopen 4 didn't inject the accurate dose: possible, hyperglycemia and entered into coma: unlikely, fills the syringes from the penfills: possible.Reporter's causality ( insulatard penfill hm(ge) 3.0 ml) - novopen 4 didn't inject the accurate dose: unknown, hyperglycemia and entered into coma: probable, fills the syringes from the penfills: unknown.Company's causality ( insulatard penfill hm(ge) 3.0 ml) - novopen 4 didn't inject the accurate dose: possible, hyperglycemia and entered into coma: unlikely, fills the syringes from the penfills: possible.Company comment: 'diabetic hyperglycemic coma' was assessed as listed event according to novo nordisk current ccds on insulatard.Information on compliance to treatment, hba1c values at the time of treatment, any recent changes in insulin regimen, concomitant medications, concurrent medical conditions are all required for thorough medical assessment.Patient's condition of type 1 diabetes mellitus was assessed as a potential confounder for diabetic hyperglycemic coma.Based on available information diabetic hyperglycemic coma was assessed to be unlikely related to insulatard.This single case report is not considered to change the current knowledge of the safety profile of insulatard.

Event Description

Case description: investigation results: insulatard penfill 3 ml 100iu/ml - batch unknown.No investigation was possible, because neither sample nor batch.Number was available.Novopen 4 - batch unknown.No investigation was possible, because neither sample nor batch.Number was available.Since last submission the case has been updated with the following: investigational results received.Manufacturer's comment updated.Narrative updated accordingly.Company comment: 14-aug-2019: as the device (novopen 4) has not been returned to novo nordisk a/s for investigation and only 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 argus case (b)(6).'diabetic hyperglycemic coma' was assessed as listed event according to novo nordisk current ccds on insulatard.Information on compliance to treatment, hba1c values at the time of treatment, any recent changes in insulin regimen, concomitant medications, concurrent medical conditions are all required for thorough medical assessment.Patient's condition of type 1 diabetes mellitus was assessed as a potential confounder for diabetic hyperglycemic coma.Based on available information diabetic hyperglycemic coma was assessed to be unlikely related to insulatard.This single case report is not considered to change the current knowledge of the safety profile of insulatard.H3 continued: evaluation summary.Novopen 4 - batch 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: 8841298
• MDR Text Key: 152656871
• Report Number: 9681821-2019-00048
• 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,study
• Type of Report: Initial,Followup
• Report Date: 06/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2019
• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Weight: 70