• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

NOVO NORDISK A/S, MEDICAL SYSTEMS NOVOPEN 4 INSULIN DELIVERY DEVICE Back to Search Results
Model Number N/A
Device Problem Failure to Deliver (2338)
Patient Problem Hyperglycemia (1905)
Event Type  Injury  
Event Description
Event verbatim [preferred term] (related symptoms if any separated by commas). Blood glucose is always high (500 mg/dl) [blood glucose increased]. Pen 1 piston rod stuck inside it's place and did not move at all [device mechanical issue]. Pen 2 didn't inject the insulin as the dose counter returned to 2 iu only and stopped from moving [device failure]. Case description: this serious spontaneous case from (b)(6) was reported by a consumer as "blood glucose is always high (500 mg/dl)(blood glucose increased)" with an unspecified onset date, "pen 1 piston rod stuck inside it's place and did not move at all(device mechanical jam)" with an unspecified onset date, "pen 2 didn't inject the insulin as the dose counter returned to 2 iu only and stopped from moving(device failure)" with an unspecified onset date, and concerned a (b)(6) years old female patient who was treated with novopen 4 (insulin delivery device) from unknown start date for "diabetes mellitus", , novopen 4 (insulin delivery device) from unknown start date for "diabetes mellitus", , actrapid penfill (insulin human) solution for injection, 100 iu/ml, (dose, frequency & route used-18 iu, tid, unknown) from unknown start date and ongoing for "diabetes mellitus", , insulatard penfill (insulin human) suspension for injection, 100 iu/ml, (dose, frequency & route used-20 iu, tid, unknown) from unknown start date and ongoing for "diabetes mellitus". Patient's height, weight and body mass index (bmi) were not reported. Current condition: diabetes mellitus(type and duration not reported), anemia. Concomitant products included - iron, vitamin b1 nos;vitamin b12 nos, calcium, vitamin b2 [riboflavin]. On unknown date about 6 or 7 months ago at time of reporting, patient blood glucose reached 500 mg/dl. It was reported that the patient had issues with 2 novopen 4, as they didn't inject the insulin normally as dose button is hardly pressed during injection as patient adjusts the dose counter on 14 iu but it's injects in 5 or 4 times of pressing the dose button. Pen 1 novopen 4, during the training the mechanical part , the piston rod stuck inside it's place and did not move at all. Pen 2 novopen 4 mechanical part worked normally after adjusting the dose counter to 60 iu and pressing the dose button with a normal movement of the piston rod and by trying a new needle and new penfill and adjusting dose counter on 8 iu the pen didn't inject the insulin as the dose counter returned to 2 iu only and stopped from moving. It was reported that, the pen wasn't preserved in the fridge and needle was changed daily then pen training was offered by using new needle and new penfill. There was no recent changes in diet or exercise/physical activity and no co-existing conditions or concomitant medications leading to increased insulin requirements. Batch numbers: novopen 4: fvg8045. Novopen 4: not reported. Actrapid penfill: asku. Insulatard penfill: asku. Action taken to novopen 4 was reported as not reported. Action taken to novopen 4 was reported as not reported. Action taken to actrapid penfill was not reported. Action taken to insulatard penfill was not reported. The outcome for the event "blood glucose is always high (500 mg/dl)(blood glucose increased)" was not yet recovered. The outcome for the event "pen 1 piston rod stuck inside it's place and did not move at all(device mechanical jam)" was not reported. The outcome for the event "pen 2 didn't inject the insulin as the dose counter returned to 2 iu only and stopped from moving(device failure)" was not reported. References included: reference type: e2b company number. Reference id#: (b)(6). Reference notes: e2b company number. Reporter comment: date and time of the last dose of the suspected product prior to the event was mainly am dose and after one hour of taking it.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameNOVOPEN 4
Type of DeviceINSULIN 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 Key12518794
MDR Text Key272897015
Report Number9681821-2021-00058
Device Sequence Number1
Product Code FMF
Combination Product (y/n)Y
Reporter Country CodeEG
PMA/PMN Number
20-986
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Reporter Occupation
Type of Report Initial
Report Date 09/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number185490
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/05/2021
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 09/23/2021 Patient Sequence Number: 1
Treatment
CALCIUM (CALCIUM).; IRON (IRON).; VITAMIN B1 NOS,VITAMIN B12 NOS.; VITAMIN B2 [RIBOFLAVIN] (VITAMIN B2 [RIBOFLAVIN]).
-
-