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

Model Number N/A

Device Problems Labelling, Instructions for Use or Training Problem (1318); Device Difficult to Setup or Prepare (1487); Failure to Deliver (2338); Delivery System Failure (2905); Device Operates Differently Than Expected (2913); Infusion or Flow Problem (2964); No Flow (2991)

Patient Problems Bacterial Infection (1735); Hyperglycemia (1905); Unspecified Infection (1930); Diabetic Ketoacidosis (2364)

Event Date 10/12/2017

Event Type  Injury  

Event Description

Diabetic ketoacidosis [diabetic ketoacidosis], hyperglycaemia [hyperglycaemia], the test is performed with the piston rod in the position indicated by the manufacturer, it did not trigger when the dose button was activated and therefore the insulin did not flow out [device failure], did not follow the instructions in the insert regarding testing the insulin flow before injecting the insulin [wrong technique in product usage process]. Case description: this serious spontaneous regulatory authority case received via (b)(6) from (b)(6) was reported by a consumer as "diabetic ketoacidosis" with an unspecified onset date, "hyperglycemia " with an unspecified onset date, "the test is performed with the piston rod in the position indicated by the manufacturer, it did not trigger when the dose button was activated and therefore the insulin did not flow out" with an unspecified onset date, "did not follow the instructions in the insert regarding testing the insulin flow before injecting the insulin" with an unspecified onset date, and concerned a female patient (age between 10-18 years) who was treated with novopen 4 (insulin delivery device) from unknown start date due to "device therapy", actrapid penfill (insulin human) from unknown start date and ongoing for unknown indication" and unknown dose and frequency, insulatard penfill (insulin human) from unknown start date and ongoing for unknown indication and unknown dose and frequency. Patient's height, weight and body mass index: not reported. Medical history was not provided. It was reported that the patient had diabetic ketoacidosis, a few days after the patient started using penfill and novopen 4. It was reported that when the test was performed with the piston rod in the position indicated by the manufacturer, it did not trigger when the dose button was activated and therefore the insulin did not flow out, leading to problems in the application of the medication causing hyperglycemia. The patient was recovered and then the device was changed and the patient was retrained in the use of penfill and novopen 4. Also, it was reported that the patient did not follow the instructions in the insert regarding testing the insulin flow before injecting the insulin. Action taken to novopen 4 was not reported. Action taken to actrapid penfill was not reported. Action taken to insulatard penfill was not reported. The outcome for the event "diabetic ketoacidosis" was recovered. The outcome for the event "hyperglycemia " was recovered. The outcome for the event "the test is performed with the piston rod in the position indicated by the manufacturer, it did not trigger when the dose button was activated and therefore the insulin did not flow out" was not reported. The outcome for the event "did not follow the instructions in the insert regarding testing the insulin flow before injecting the insulin" was not reported. This case is linked to (b)(4) (same reporter). Company comment: in this case the reported events are listed. More details are needed for the proper medical evaluation. Reporter comment: the moh classified the events as related to novopen 4, not to the insulins (actrapid and insulatard).

• 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: 7288992
• MDR Text Key: 100692247
• Report Number: 9681821-2018-00013
• 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,health profe
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/01/2018
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 07/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 185490
• Device Lot Number: FVG9827 -1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 08/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 02/22/2018 Patient Sequence Number: 1