• 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 Problem Device Difficult to Setup or Prepare (1487)
Patient Problem Hyperglycemia (1905)
Event Date 01/01/2020
Event Type  Injury  
Event Description
(related symptoms if any separated by commas), blood sugar over 400-500 mg/dl [blood glucose increased], pen needing to be primed up to 5 times before any insulin comes out of the pen [device difficult to use], blood sugars not able to get under 400-500 mg/dl due to particular batch [product quality issue]. Case description: this serious spontaneous case from the (b)(6) was reported by a consumer as "blood sugar over 400-500 mg/dl(blood glucose increased)" beginning on (b)(6) 2020, "pen needing to be primed up to 5 times before any insulin comes out of the pen(device difficult to use)" beginning on (b)(6) 2020, "blood sugars not able to get under 400-500 mg/dl due to particular batch(product lot specific issue)" beginning on (b)(6) 2020, and concerned a (b)(6) female patient who was treated with novopen echo (insulin delivery device) from unknown start date for "type 1 diabetes mellitus", novolog penfill (insulin aspart) from (b)(6) 2020 and ongoing for "type 1 diabetes mellitus" (dose and frequency sliding scale). The patient's height, weight and body mass index (bmi): not reported. Dosage regimens: novopen echo: novolog penfill: (b)(6) 2020 to not reported (dosage regimen ongoing). Current condition: type 1 diabetes mellitus (duration : not reported). On (b)(6) 2020, the patient had blood sugar over 400-500 mg/dl. Patient's mother reported the patient receiving therapy with novolog penfill cartridges and novopen echo was unable to get the blood sugars under 400-500 mg/dl. The mother reported being unable to get the blood sugar under 400 mg/dl when the patient was home, but the patient's blood sugar was fine during school. The mother reported the blood sugars were high with the particular batch and that she would need to prime the novopen echo up to 5 times before any insulin would come out of the pen. Batch numbers of novopen echo is jvgr852-7. Batch numbers of novolog penfill is hs67e16. Action taken to novopen echo was not reported. Action taken to novolog penfill was not reported. The outcome for the event "blood sugar over 400-500 mg/dl(blood glucose increased)" was not recovered. The outcome for the event "pen needing to be primed up to 5 times before any insulin comes out of the pen(device issue)" was not reported. The outcome for the event "blood sugars not able to get under 400-500 mg/dl due to particular batch(product lot specific issue)" was not reported.
 
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
Manufacturer Contact
p.o. box 846
plainsboro, NJ 08536
8007276500
MDR Report Key9828718
MDR Text Key192421821
Report Number9681821-2020-00015
Device Sequence Number1
Product Code FMF
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K123766
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/13/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2021
Device Model NumberN/A
Device Catalogue Number185459
Device Lot NumberJVGR852-7
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
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
Date Device Manufactured03/06/2019
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: 03/13/2020 Patient Sequence Number: 1
-
-