• 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 Device Operates Differently Than Expected (2913); Infusion or Flow Problem (2964)
Patient Problem Hyperglycemia (1905)
Event Type  Injury  
Event Description
Event verbatim (preferred term). Blood sugar went high and would not come down (blood glucose increased) nothing was actually going in, pen failed (device failure). Something is wrong with the pusher (device issue). Case description: this serious spontaneous case from spain was reported by a consumer as "blood sugar went high and would not come down" with an unspecified onset date, "nothing was actually going in, pen failed" with an unspecified onset date, "something is wrong with the pusher" with an unspecified onset date, and concerned a male patient (age not reported) who was treated with novopen echo (insulin delivery device) from unknown start date due to device therapy. The patient's height, weight and body mass index were not reported. Medical history was not provided. On an unspecified date, while on a holiday, the patient's blood sugar went high (value not reported) and would not come down. The patient went 36 hours without food, worrying about what could have happened. The patient realized that in spite of the pen telling how many units the patient had injected, nothing was actually going in, and pen failed. There was something wrong with the pusher. The patient bought a replacement which worked and patient recovered from high blood sugar. It was reported that patient was saved from hospital and further medical expenses by the freestyle libre the patient was wearing. Action taken to novopen echo was not reported. The outcome for the event "blood sugar went high and would not come down" was recovered. The outcome for the event "nothing was actually going in, pen failed" was not reported. The outcome for the event "something is wrong with the pusher" was not reported. Reporter comment: i managed to buy a replacement pen in madrid and the problem went away. If i had not been in madrid and wearing a freestyle libre (not cheap) i would have wound up in hospital. Your untruthful pen is a real hazard.
 
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
Manufacturer (Section G)
NOVO NORDISK A/S
krogshoejvej 55
bagsvaerd, 2880
DA 2880
Manufacturer Contact
p.o. box 846
plainsboro, NJ 08536
8007276500
MDR Report Key7584221
MDR Text Key110573240
Report Number9681821-2018-00036
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K123766
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Reporter Occupation Patient
Type of Report Initial,Followup,Followup
Report Date 05/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberNOT PROVIDED
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/04/2019
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: 06/08/2018 Patient Sequence Number: 1
-
-