• 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 Erratic or Intermittent Display (1182)
Patient Problems Hypoglycemia (1912); Overdose (1988)
Event Type  Injury  
Event Description
(related symptoms if any separated by commas), hypoglycaemic episode [hypoglycaemia], injected twice (overdose) [overdose], pen had no display [device information output issue]. Case description: this serious spontaneous case from (b)(6) was reported by a consumer as "hypoglycaemic episode (hypoglycaemic episode)" with an unspecified onset date, "injected twice (overdose)(overdose)" with an unspecified onset date, "pen had no display(device information output issue)" with an unspecified onset date, and concerned a (b)(6) male patient who was treated with novopen 4 (insulin delivery device) from unknown start date for "type 2 diabetes mellitus", novorapid penfill (insulin aspart) from unknown start date and ongoing for "type 2 diabetes mellitus" (dose and frequency unknown). Patient's height: 178 cm, patient's weight: (b)(6), patient's bmi: 29. 036. Current condition: type 2 diabetes mellitus (duration not reported). Treatment included - glucose. On an unspecified date (reported as about four years ago), the patient experienced a hypoglycaemic episode during the use of novopen 4 and novorapid penfill. The patient's blood glucose level was reported to be 29 mg/dl. It was reported that the pen had no display and the patient injected twice (overdose) and due to which the patient was admitted to hospital and was hospitalized for 4 days. Batch number of novopen 4 and novorapid penfill has been requested. Action taken to novopen 4 was not reported. Action taken to novorapid penfill was reported as no change. The outcome for the event "hypoglycaemic episode(hypoglycaemic episode)" was not reported. The outcome for the event "injected twice (overdose)(overdose)" was not reported. The outcome for the event "pen had no display(device information output issue)" was not reported. Reporter comment: alternative aetiology: overdose.
 
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
Manufacturer Contact
p.o. box 846
plainsboro, NJ 08536
8007276500
MDR Report Key9793110
MDR Text Key192420145
Report Number9681821-2020-00013
Device Sequence Number1
Product Code FMF
Combination Product (y/n)Y
PMA/PMN Number
20-986
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Type of Report Initial,Followup
Report Date 12/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/05/2020
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/13/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 03/05/2020 Patient Sequence Number: 1
-
-