• 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 PDS 328 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 PDS 328 INSULIN DELIVERY DEVICE Back to Search Results
Model Number N/A
Device Problems Excess Flow or Over-Infusion (1311); Obstruction of Flow (2423)
Patient Problem Hypoglycemia (1912)
Event Date 10/21/2019
Event Type  Injury  
Event Description
Hypoglycemia [hypoglycaemia], pen only show 0. 5 units (administered another dosage 0. 5 units) [extra dose administered], novopen echo is setting the wrong dosage [device malfunction]. Case description: study id: (b)(6). Study description: trial title: to support the patient in the beginning of treatment with novo nordisk products for diabetes mellitus and obesity. The patient is instructed on how to use, transport and store the products, and receives orientation by phone, site or in person by a nurse. Patient's height: 120 cm. Patient's weight: (b)(6) kg. Patient's body mass index (bmi): 11. 80555560. This serious solicited report from (b)(6) was reported by a consumer as "hypoglycemia(hypoglycemia)" beginning on (b)(6) 2019 , "pen only show 0. 5 units (administered another dosage 0. 5 units)(extra dose administered)" beginning on (b)(6) 2019 , "novopen echo is setting the wrong dosage(device malfunction)" with an unspecified onset date and concerned a (b)(6) years old female patient who was treated with novopen echo pds 328 (insulin delivery device) from unknown start date for "type 1 diabetes mellitus". Current condition: type 1 diabetes mellitus (duration not reported). Concomitant medications included - tresiba flextouch u100(insulin degludec) solution for injection, 100 u/ml (b)(6) 2019 to ongoing and novorapid penfill(insulin aspart) solution for injection, 100 u/ml (b)(6) 2019 to ongoing. Patient did not use other concomitant products and did not have relevant medical history. It was reported that, novopen echo was setting the wrong dosage. On (b)(6) 2019, administered 1. 5 units and the pen only showed 0. 5 units, because of that mother of the patient delivered another dosage to achieve 2 iu. Due to this, patient had hypoglycaemia. The blood glucose range from 70-180 mg/dl went to 56 mg/dl. On the same day, a correction was made. Patient was given sugar to treat hypoglycaemia. It was reported that non-novonordisk needles used. One needle per application. The flow verification was performed and the pen marked 2 u in the test however the patient indicates the failure is intermittent and does not want to risk it. Batch numbers: novopen echo pds 328: jvgr452-1. Action taken to novopen echo pds 328 was not reported. On (b)(6) 2019 the outcome for the event "hypoglycemia(hypoglycemia)" was recovered. The outcome for the event "pen only show 0. 5 units (administered another dosage 0. 5 units to achieve 2 iu)(extra dose administered)" was not reported. The outcome for the event "novopen echo is setting the wrong dosage(device malfunction)" was not reported. Reporter's causality (novopen echo pds 328) - hypoglycemia(hypoglycemia) : possible. Pen only show 0. 5 units (administered another dosage 0. 5 units)(extra dose administered) : possible. Novopen echo is setting the wrong dosage(device malfunction) : possible. Company's causality (novopen echo pds 328) - hypoglycemia(hypoglycemia) : possible. Pen only show 0. 5 units (administered another dosage 0. 5 units)(extra dose administered) : possible. Novopen echo is setting the wrong dosage(device malfunction) : possible. Evaluation summary: name : novopen echo, batch number : jvgr452-1, the product was not returned for examination. The batch documentation was reviewed. No abnormalities relating to the observed problem was found.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameNOVOPEN ECHO PDS 328
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 Key9415721
MDR Text Key185267979
Report Number9681821-2019-00085
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,study
Type of Report Initial,Followup
Report Date 11/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/05/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2020
Device Model NumberN/A
Device Catalogue Number185459
Device Lot NumberJVGR452-1
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/12/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/30/2019
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: 12/05/2019 Patient Sequence Number: 1
-
-