• 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 Defective Device (2588)
Patient Problem Diabetic Ketoacidosis (2364)
Event Date 03/01/2021
Event Type  Injury  
Event Description
Event verbatim [preferred term] (related symptoms if any separated by commas) mild diabetic ketoacidosis with high blood sugar readings in the 300s mg/dl two consecutive nights [diabetic ketoacidosis] novopen echo was malfunctioning [device malfunction]. Case description: this serious spontaneous case from the united states was reported by a consumer as "dka with high blood sugar readings in the 300s mg/dl two consecutive nights (diabetic ketoacidosis)" beginning on (b)(6) 2021, "novopen echo was malfunctioning (device malfunction)" beginning on (b)(6) 2021, and concerned an adult female patient who was treated with novopen echo (insulin delivery device) from unknown start date for "type 1 diabetes mellitus", , novolog penfill (insulin aspart) solution for injection, 100 u/ml (dose, frequency & route used - unk, unknown) from unknown start date for "drug use for unknown indication", current condition: type 1 diabetes mellitus (since (b)(6) 2020). On an unknown date of (b)(6) 2021, the patient experienced that novopen echo was malfunctioning and as a result the patient experienced a mild diabetic ketoacidosis with symptom of dizziness and high blood sugar readings in the 300's mg/dl two consecutive nights. It was reported that patient does not want to use the novopen echo ever again. Patient does not feel safe using the novo pen echo. Batch numbers: novopen echo: kvg0m24-3, novolog penfill: ks6ca00. Action taken to novopen echo was reported as product discontinued. Action taken to novolog penfill was not reported. The outcome for the event "dka with high blood sugar readings in the 300s mg/dl two consecutive nights(diabetic ketoacidosis)" was recovering/resolving. The outcome for the event "novopen echo was malfunctioning(device malfunction)" was not reported. Preliminary manufacturer's comment: (b)(6) 2021: the suspected device novopen echo 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
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 Key11507338
MDR Text Key254020403
Report Number9681821-2021-00013
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 03/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number185459
Device Lot NumberKVG0M24-3
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/20/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/19/2020
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: 03/17/2021 Patient Sequence Number: 1
-
-