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

Model Number N/A

Device Problem Mechanical Jam (2983)

Patient Problem Hypoglycemia (1912)

Event Date 11/23/2021

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas) patient's blood glucose decreased [blood glucose decreased] patient received three injections subcutaneously at the same time (first two injections didn't completed) [extra dose administered] pushing rod of the syringe could not move the liquid medicine into the needle [device mechanical issue] case description: this serious spontaneous case from (b)(6) was reported by a health care professional nos as "patient's blood glucose decreased(blood glucose decreased)" beginning on (b)(6) 2021, "patient received three injections subcutaneously at the same time (first two injections didn't completed)(extra dose administered)" beginning on (b)(6) 2021, "pushing rod of the syringe could not move the liquid medicine into the needle(device mechanical jam)" beginning on (b)(6) 2021, and concerned a (b)(6) years old male patient who was treated with novopen 4 (insulin delivery device) from (b)(6) 2021 for "diabetes mellitus". Patient's height, weight and body mass index (bmi) were not reported. Dosage regimens: novopen 4: (b)(6) 2021 to not reported; current condition: diabetes mellitus (type and duration not reported). On (b)(6) 2021, when the patient adjusted the scale for subcutaneous injection at home, the patient found that the pushing rod of the syringe could not move, so the patient pulled out the syringe and observed that there was no abnormality in the appearance. The patient still cannot completed second subcutaneous injection (the first two injections didn't completed) therefore patient went to community clinic and changed a new injection pen to complete the subcutaneous injection under the condition of eliminating that the injection needle was blocked. The patient received three injections subcutaneously at the same time, leaded patient's blood glucose decreased (severe injury). Batch numbers: novopen 4: kvgy715-1. Action taken to novopen 4 was not reported. The outcome for the event "patient's blood glucose decreased (blood glucose decreased)" was not reported. The outcome for the event "patient received three injections subcutaneously at the same time (first two injections didn't completed) (extra dose administered)" was not reported. The outcome for the event "pushing rod of the syringe could not move the liquid medicine into the needle (device mechanical jam)" was not reported. References included: reference type: e2b authority number. Reference id#: (b)(6). Reference notes: nmpa (national medical products administration), (b)(6).

• 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: 13008963
• MDR Text Key: 282264131
• Report Number: 9681821-2021-00091
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: 20-986
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2021
• 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: KVGY715-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2020
• 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: 12/15/2021 Patient Sequence Number: 1