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

Model Number N/A

Device Problem Failure to Prime (1492)

Patient Problem Diabetic Ketoacidosis (2364)

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas) dka (diabetic ketoacidosis) [diabetic ketoacidosis].Patient not priming the insulin, was not getting the insulin [device failure].Case description: this serious spontaneous case from the (b)(6) was reported by a nurse as "dka (diabetic ketoacidosis)" with an unspecified onset date, " patient not priming the insulin, was not getting the insulin" with an unspecified onset date, and concerned an adolescent male patient who was treated with novopen echo (insulin delivery device) from unknown start date due to "device therapy", , tresiba (insulin degludec) from unknown start date and ongoing due to "drug use for unknown indication" (dose and frequency unknown), , novorapid penfill (insulin aspart) from unknown start date and ongoing due to "drug use for unknown indication" (dose and frequency unknown).The patient's height, weight and body mass index.Medical history was not provided.It was reported that patient was switching between basal and bolus cartridges into one pen.On an unknown date patient was not priming the insulin and so was not getting insulin and ended up in dka (diabetic ketoacidosis).On an unknown date the patient was hospitalized for dka (diabetic ketoacidosis).The batch number of novopen echo, tresiba and novorapid penfill were requested.Action taken to novopen echo was reported as no change.Action taken to tresiba was reported as no change.Action taken to novorapid penfill was reported as no change.The outcome for the event "dka (diabetic ketoacidosis)" was not reported.The outcome for the event "patient not priming the insulin, was not getting the insulin" was not reported.No further information available.

Event Description

Case description: this serious spontaneous case from the united kingdom was reported by a nurse as "dka (diabetic ketoacidosis)(diabetic ketoacidosis)" with an unspecified onset date, "patient not priming the insulin, was not getting the insulin(device failure to prime)" with an unspecified onset date, and concerned a adolescent male patient who was treated with novopen echo (insulin delivery device) from unknown start date due to "device therapy", , tresiba (insulin degludec) from unknown start date and ongoing due to "drug use for unkown indication" (dose and frequency unknown), , novorapid penfill (insulin aspart) from unknown start date and ongoing due to "drug use for unknown indication" (dose and frequency unknown).The patient's height, weight and body mass index was not reported the outcome for the event "dka (diabetic ketoacidosis)" was not reported.The outcome for the event "patient not priming the insulin, was not getting the insulin(device failure to prime)" was not reported.Investigation results: name: tresiba - batch unknown name: novorapid® penfill® 3 ml - batch unknown name: novopen echo® - batch unknown no investigation was possible, because neither sample nor batch number was available.Since last submission, the case has been updated with the below information: -investigation result updated as "no investigation was possible, because neither sample nor batch number was available".-manufacture comment updated.-narrative updated accordingly.Manufacturer's comment: 05-jun-2020: as the device (novopen echo) has not been returned to novo nordisk a/s and batch number was also not available, no investigation was possible.Considering that patient was not priming the device before injection, it could be related to product handling error.That has led to hyperglycaemia and diabetic ketoacidosis.However a clear root cause of the experienced adverse event could not be identified.Continued: evaluation summary name: novopen echo, batch : unknown no investigation was possible, because neither sample nor batch number was available.

• Brand Name: NOVOPEN ECHO
• Type of Device: INSULIN DELIVERY DEVICE
• Manufacturer (Section D): NOVO NORDISK A/S, MEDICAL SYSTEMS; hilleroed, ; DA
• MDR Report Key: 9213459
• MDR Text Key: 167986713
• Report Number: 9681821-2019-00071
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• PMA/PMN Number: K123766
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 09/23/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2019
• 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 Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization