• 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 3 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 3 INSULIN DELIVERY DEVICE Back to Search Results
Model Number N/A
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Code Available (3191)
Event Type  Injury  
Event Description
Low insulin levels. Pen reported as being defective. Case description: this serious spontaneous case from the united kingdom was reported by a pharmacist as "low insulin levels" and "pen reported as being defective" both with an unspecified onset date and concerned a male patient who was treated with novopen 3 (insulin delivery device) both from an unknown start date for device therapy. Patient's height, weight and body mass index: not reported. Medical history was not provided. Concomitant medication: levemir (insulin detemir) solution for injection,. 0024 mol/l. It was reported that patient was admitted to hospital due to low insulin levels. The drug in the pen was levemir. Pen was also reported as defective when the patient was admitted to hospital. Action taken to novopen 3 was not reported. The outcome for the event "low insulin levels" was not reported. The outcome for the event "pen reported as being defective" was not reported. This case was re-classified from nonserious to serious on 16-dec-2016 due to addition hospitalization for the event "low insulin levels" and "device became defective".
 
Event Description
Event verbatim [preferred term] (related symptoms if any separated by commas), pen hadn't been delivering the correct dose and the patient received a low dose of insulin [incorrect dose administered by device], pen reported as being defective [device defective]. Case description: this serious spontaneous case from (b)(6) was reported by a pharmacist as "pen hadn't been delivering the correct dose and the patient received a low dose of insulin" and "pen reported as being defective" both with an unspecified onset date and concerned a male patient who was treated with novopen 3 (insulin delivery device) both from an unknown start date for device therapy. Patients wife said that the pen hadn't been delivering the correct dose and the patient received a low dose of insulin resulting in a hospital admission. The outcome for the event "pen hadn't been delivering the correct dose and the patient received a low dose of insulin" was not reported. The outcome for the event "pen reported as being defective" was not reported. Investigation result: name: novopen® 3 batch: unknown. No investigation was possible, because neither sample nor batch number was available. Since last submission the case has been updated with following information: -narrative updated, -investigation result, -final manufacturer comment. Final manufacturer comment: update 23-jan-2017: as novo pen 3 has not been returned to novo nordisk (b)(4) for investigation and only very limited information regarding the handling of suspected novo pen 3 is available, it is not possible to identify a clear root-cause of the experienced adverse event and thus find similar incidents to the one reported in (b)(4). Evaluation summary: no investigation was possible, because neither sample nor batch number was available.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameNOVOPEN 3
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
novoprod novo nordisk inc.
p.o. box 846
plainsboro, NJ 08536
8007276500
MDR Report Key6228260
MDR Text Key64024956
Report Number9681821-2017-00001
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
19-938
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 12/08/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number185290
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/06/2017
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: 01/06/2017 Patient Sequence Number: 1
Treatment
LEVEMIR (INSULIN DETEMIR) SOL FOR INJ .0024 MOL/L
-
-