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 Problem Hypoglycemia (1912)

Event Date 11/09/2021

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas). Hypoglycaemic episode blood glucose level 2. 1 mmol/l [hypoglycaemia]. Device malfunction [device malfunction]. Case description: this serious spontaneous case from (b)(6) was reported by a consumer as "hypoglycaemic episode blood glucose level 2. 1 mmol/l (hypoglycaemic episode)" beginning on (b)(6) 2021, "device malfunction (device malfunction)" with an unspecified onset date, and concerned a female patient who was treated with novopen 4 (insulin delivery device) from unknown start date for "type 2 diabetes mellitus", , novofine (needle) from unknown start date for "type 2 diabetes mellitus", mixtard 30/70 penfill (insulin human) suspension for injection, 100 iu/ml (dose, frequency & route used- 16 iu, qd, unknown and regimen #2- 18 iu, qd, unknown) from unknown start date and ongoing for "type 2 diabetes mellitus", concomitant products included - metformin. Patient's height, weight and body mass index (bmi) was not reported. Current condition: type 2 diabetes mellitus (duration was not reported). On an unspecified date in (b)(6) 2021, the patient's blood glucose was 9. 8 mmol/l. On (b)(6) 2021, patient's blood glucose level was 2. 1 mmol/l. It was reported that patient was given lemonade and toast to bring blood glucose levels back up. Patient was given the choice to go to hospital or straight to the local doctor. Patient chose to go to doctor and over there patient's blood glucose level was 2. 9 mmol/l. The physician advised the patient to get a new novopen 4 and the patient obliged. Patient had her diabetes medications changed in the past weeks. Her mixtard 30/70 dose was changed from 16 units last week to 18 units this week and she discontinued her metformin tablets. Batch numbers of novopen 4 and novofine was requested. Action taken to novopen 4 was reported as product discontinued due to ae. Action taken to novofine was reported as no change. Action taken to mixtard 30/70 penfill was reported as no change. On (b)(6) 2021 the outcome for the event "hypoglycaemic episode blood glucose level 2. 1 mmol/l (hypoglycaemic episode)" was recovered. The outcome for the event "device malfunction (device malfunction)" was not reported.

• 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 3400
• Manufacturer Contact: p.o. box 846; plainsboro,, NJ 08536 ; 8007276500
• MDR Report Key: 12907795
• MDR Text Key: 286938262
• Report Number: 9681821-2021-00078
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• Reporter Country Code: AS
• PMA/PMN Number: 20-986
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer

Reporter Occupation

• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: 185490
• Device Lot Number: HVGP048-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2021
• Date Manufacturer Received: 03/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2018
• 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: 12/01/2021 Patient Sequence Number: 1

Treatment

METFORMIN (METFORMIN).