• 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 ECHO 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 ECHO INSULIN DELIVERY DEVICE Back to Search Results
Model Number N/A
Device Problems Defective Component (2292); Defective Device (2588); Mechanical Jam (2983)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Type  Injury  
Event Description
Event verbatim [preferred term] (related symptoms if any separated by commas). The needle and the pen were stuck in her skin after a vacuum had been created [injury associated with device]. The piston did not return to its proper position and the pen unlocks on its own [device malfunction]. This serious spontaneous case from greece was reported by a consumer as "the needle and the pen were stuck in her skin after a vacuum had been created(injury associated with device)" with an unspecified onset date, "the piston did not return to its proper position and the pen unlocks on its own(device malfunction)" with an unspecified onset date, and concerned a female patient who was treated with novopen echo (insulin delivery device) from unknown start date for "type 1 diabetes mellitus", novofine 4mm (32g) (needle) from unknown start date for "type 1 diabetes mellitus". Current condition: type 1 diabetes mellitus. Concomitant products included - novorapid penfill(insulin aspart) solution for injection, 100 iu/ml. On an unknown date, while the patient was administering dose of novorapid penfill with novopen echo, the needle and the pen were stuck in skin after a vacuum had been created. They had to go to the outpatient department of the hospital to have it removed. The doctor who removed it explained that it stuck because the piston did not return to its proper position. It was also reported that the novopen echo was stored at the refridgerator (2-8 celsius degrees) due to high temperature during summer and the patient had observed that the pen unlocked on its own. Batch number of novopen echo and novofine 4mm (32g) was requested. Action taken to novopen echo was reported as product discontinued. Action taken to novofine 4mm (32g) was not reported. The outcome for the event "the needle and the pen were stuck in her skin after a vacuum had been created(injury associated with device)" was recovered. The outcome for the event "the piston did not return to its proper position and the pen unlocks on its own(device malfunction)" was recovered. Preliminary manufacturer's comment: 12-jul-2021: the suspected device (novopen echo) and novofine needle has not been returned to novo nordisk for evaluation. No conclusion is reached.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameNOVOPEN ECHO
Type of DeviceINSULIN DELIVERY DEVICE
Manufacturer (Section D)
NOVO NORDISK A/S, MEDICAL SYSTEMS
hilleroed,,
DA
MDR Report Key12195435
MDR Text Key262420765
Report Number9681821-2021-00038
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
K123766
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Type of Report Initial,Followup,Followup,Followup
Report Date 07/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/19/2021
Device Model NumberN/A
Device Catalogue Number185458
Device Lot NumberJVGT271
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/22/2021
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/20/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/20/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/20/2021 Patient Sequence Number: 1
Treatment
NOVORAPID PENFILL (INSULIN ASPART)
-
-