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

Model Number N/A

Device Problem Inaccurate Delivery (2339)

Patient Problem Hypoglycemia (1912)

Event Type  Injury  

Event Description

Hypoglycaemic events [hypoglycaemia].Novopen echo is dosing inaccurately [incorrect dose administered by device].Two other hypoglycaemic events [hypoglycaemia].Case description: this serious spontaneous case from (b)(6) was reported by a consumer as "hypoglycaemic events(hypoglycaemia)" with an unspecified onset date, "novopen echo is dosing inaccurately(incorrect dose administered by device)" with an unspecified onset date, "two other hypoglycaemic events(hypoglycaemia)" with an unspecified onset date, and concerned a female patient who was treated with novopen echo (insulin delivery device) from unknown start date and ongoing for "diabetes mellitus type 1", novorapid penfill (insulin aspart) from unknown start date and ongoing for "diabetes mellitus type 1" (dose and frequency unknown), a non-novo nordisk suspect product lantus (insulin glargine) from unknown start date for "diabetes mellitus type 1" (dose and frequency unknown), patient's height, weight and bmi: not reported.Current condition: diabetes mellitus type 1.Treatment included - glucose.On an unknown date, the patient experienced hypoglycaemic events - ambulance called to last event and liquid glucose was administered - not taken to hospital.It was reported that the patient thinks her novopen echo was dosing inaccurately.The patient also had two other hypoglycaemic events which she had treated herself with carbohydrates and recovered.Batch numbers: novopen echo: cv40227; novorapid penfill: asku.Action taken to novopen echo red was not reported.Action taken to novorapid penfill was reported as no change.Action taken to lantus was not reported.The outcome for the event "hypoglycaemic events(hypoglycaemia)" was recovered.The outcome for the event "novopen echo is dosing inaccurately(incorrect dose administered by device)" was not reported.The outcome for the event "two other hypoglycaemic events(hypoglycaemia)" was recovered.No further information available.(b)(4).Reporter comment: reporter does not wish to take this matter further as she believes the faulty novopen echo has caused the hypos.

Event Description

Case description: this serious spontaneous case from australia was reported by a consumer as "hypoglycaemic events(hypoglycaemia)" with an unspecified onset date, "novopen echo is dosing inaccurately(incorrect dose administered by device)" with an unspecified onset date, "two other hypoglycaemic events(hypoglycaemia)" with an unspecified onset date, and concerned a female patient (age not reported) who was treated with novopen echo (insulin delivery device) from unknown start date and ongoing for "diabetes mellitus type 1", novorapid penfill (insulin aspart) from unknown start date and ongoing for "diabetes mellitus type 1".Current condition: diabetes mellitus type 1 (duration not reported).Investigation results: name: novopen echo red - batch cv40227.The electronic register was checked.The readout revealed indications of unintended use of the pen.Visual and functional examinations were performed and the device was tested with a random cartridge and a novo nordisk needle 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.Confirmed: in the readout of the electronic pen memory it was revealed that the electronic display has shown two lines; - - after the dose button was fully depressed.This is because the user split the selected dose into two or more smaller doses which were delivered over a period of more than 15 minutes before the entire dose was fully delivered.The two lines in the display is a normal function of the pen to warn the user of not recommended user behaviour.The observed problem was caused by unintended use of the device.Name: novorapid penfill 3ml - batch unknown.No investigation was possible, because neither sample nor batch number was available.Since last submission, the following was updated: investigation result updated.Manufacturer's comment updated.Narrative updated accordingly.Manufacturer comment: 03-dec-2019: upon investigation of the returned sample (novopen echo), it was found to function normally.Dose accuracy was found to comply with specification.The memory display has shown two lines (- -) after the dose button was fully depressed.This is because the user split the selected dose into two or more smaller doses which were delivered over a period of more than 15 minutes before the entire dose was fully delivered.The observed problem is caused by unintended use of the device.Hypoglycaemia is assessed as listed.This single case report is not considered to change the current knowledge of the safety profile of novorapid penfill.

• Brand Name: NOVOPEN ECHO
• Type of Device: INSULIN DELIVERY DEVICE
• Manufacturer (Section D): NOVO NORDISK A/S, MEDICAL SYSTEMS; hilleroed, ; DA
• MDR Report Key: 9273654
• MDR Text Key: 183373403
• Report Number: 9681821-2019-00074
• 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: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 10/07/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/12/2014
• Device Model Number: N/A
• Device Catalogue Number: 185459
• Device Lot Number: CV40227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2019
• Date Manufacturer Received: 11/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention