• 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 Problems Device Difficult to Setup or Prepare (1487); Improper or Incorrect Procedure or Method (2017); Inaccurate Delivery (2339)
Patient Problems Hypoglycemia (1912); Loss of consciousness (2418)
Event Type  Injury  
Event Description
Event verbatim: [preferred term] (related symptoms if any separated by commas) patient injected another 40 iu then he felt dizzy and lost his consciousness [hypoglycaemic unconsciousness]. Patient injected another 40 iu then he felt dizzy and lost his consciousness [extra dose administered]. Novopen didn't inject the dose [device delivery system issue] force needed to inject feel different from normal (e) [device difficult to use]. Case description: study id: (b)(6). Study description: trial title: main objective of the programme is to help patients to understand their diabetes and maintain normal life through qualified educators who offer simple and practical information directly to the patients and also, train patients on how to use their insulin devices and needles etc. Patient's height, weight and body mass index (bmi) were not reported. This serious solicited report from egypt was reported by a consumer as "patient injected another 40 iu then he felt dizzy and lost his consciousness(hypoglycemic unconsciousness)" with an unspecified onset date , "patient injected another 40 iu then he felt dizzy and lost his consciousness (extra dose administered)" with an unspecified onset date, "novopen didn't inject the dose(device delivery system issue)" with an unspecified onset date , "force needed to inject feel different from normal (device difficult to use)" with an unspecified onset date and concerned a patient who was treated with novopen 4 (insulin delivery device) from unknown start date for "device therapy", mixtard penfill (insulin human) (dose, frequency & route used-unk, unknown) from unknown start date and ongoing for "diabetes mellitus". Dosage regimens: novopen 4: mixtard penfill: current condition: diabetes mellitus (type and duration not reported), hypertension. On an unknown date patient adjusted novopen 4 on 40 iu and tried to inject the dose but novopen did not inject the dose. On unknown date, patient injected another 40 iu and then patient felt dizzy and lost consciousness. It was reported that, force needed to inject feel different from normal (easier) and patient in general used a new needle or needle didn't attached to the pen in between injections. The cartridge holder didn't detach from the pen body accidentally or intentional. Batch numbers: novopen 4: dvg1840 mixtard penfill: asku; action taken to mixtard penfill was reported as no change. The outcome for the event "patient injected another 40 iu then he felt dizzy and lost his consciousness(hypoglycemic unconsciousness)" was not reported. The outcome for the event "patient injected another 40 iu then he felt dizzy and lost his consciousness(extra dose administered)" was not reported. The outcome for the event "novopen didn't inject the dose(device delivery system issue)" was not reported. The outcome for the event "force needed to inject feel different from normal(device difficult to use)" was not reported. Reporter's causality (novopen 4) - patient injected another 40 iu then he felt dizzy and lost his consciousness. (hypoglycemic unconsciousness) : probable. Patient injected another 40 iu then he felt dizzy and lost his consciousness(extra dose administered) : unknown. Novopen didn't inject the dose(device delivery system issue) : unknown. Force needed to inject feel different from normal(device difficult to use) : unknown. Company's causality (novopen 4) - patient injected another 40 iu then he felt dizzy and lost his consciousness. (hypoglycemic unconsciousness) : possible. Patient injected another 40 iu then he felt dizzy and lost his consciousness(extra dose administered) : possible. Novopen didn't inject the dose(device delivery system issue) : possible. Force needed to inject feel different from normal(device difficult to use) : possible. Reporter's causality (mixtard penfill) - patient injected another 40 iu then he felt dizzy and lost his consciousness. (hypoglycemic unconsciousness) : probable. Patient injected another 40 iu then he felt dizzy and lost his consciousness(extra dose administered) : unknown. Novopen didn't inject the dose(device delivery system issue) : unknown. Force needed to inject feel different from normal(device difficult to use) : unknown. Company's causality (mixtard penfill) - patient injected another 40 iu then he felt dizzy and lost his consciousness. (hypoglycemic unconsciousness) : possible. Patient injected another 40 iu then he felt dizzy and lost his consciousness(extra dose administered) : possible. Novopen didn't inject the dose(device delivery system issue) : possible. Force needed to inject feel different from normal (device difficult to use) : possible. References included: reference type: (b)(4), report duplicate. Reference id #: (b)(4). Reference notes: affiliate reference number. Reference type: (b)(4) company number. Reference id#: (b)(4). Reference notes: (b)(4) company number.
 
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 Key13042166
MDR Text Key288289936
Report Number9681821-2021-00094
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 Foreign,Study,Consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/25/2019
Device Model NumberN/A
Device Catalogue Number185490
Device Lot NumberDVG1840
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/08/2021
Date Manufacturer Received12/28/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/26/2014
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: 12/20/2021 Patient Sequence Number: 1
-
-