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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NOVO NORDISK A/S, MEDICAL SYSTEMS NOVOPEN ECHO INSULIN DELIVERY DEVICE

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NOVO NORDISK A/S, MEDICAL SYSTEMS NOVOPEN ECHO INSULIN DELIVERY DEVICE Back to Search Results
Model Number N/A
Device Problem Obstruction of Flow (2423)
Patient Problem Hyperglycemia (1905)
Event Date 09/25/2018
Event Type  Injury  
Event Description
Event verbatim [preferred term] (related symptoms if any separated by commas), hyperglycaemia (hyperglycaemia), the pen blocked (device occlusion). Case description: this serious spontaneous case from france was reported by a pharmacist as "hyperglycaemia" beginning on (b)(6) 2018, "the pen blocked" beginning on (b)(6) 2018, and concerned a (b)(6) years old female patient who was treated with novopen echo (insulin delivery device) from unknown start date due to type 1 diabetes mellitus, novorapid penfill (insulin aspart) from unknown start date due to type 1 diabetes mellitus (dose and frequency unknown). Patient's height: 173 cm; patient's weight: (b)(6); patient's bmi: 18. 37700080. Medical history included type 1 diabetes mellitus (since (b)(6) 2017) and asthma. Concomitant products included - abasaglar (insulin glargine). On (b)(6) 2018, the patient's pen blocked and following the blockage the patient experienced hyperglycaemia at 4 g/l. The patient was hospitalized on the same day and patient's glycaemia during hospitalization was 3. 82 g/l. On (b)(6) 2018, the patient's glycaemia was 2. 34 g/l. Then the patient tried again and could inject her insulin. It was reported that despite using a new needle, the problem continued. The patient stopped using novopen echo and started using novorapid flexpen in replacement of the faulty pen. Batch number of novopen echo and novorapid penfill was available. Action taken to novopen echo was reported product discontinued. Action taken to novorapid penfill was reported as product discontinued. The outcome for the event "hyperglycaemia" was unknown. The outcome for the event "the pen blocked" was unknown. Company comment: the reported events are listed. This single case report is not considered to change the current knowledge of the safety profile of novorapid (insulin aspart). Reporter comment: reporter's causality: probable.
 
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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 Key8021523
MDR Text Key125606929
Report Number9681821-2018-00069
Device Sequence Number1
Product Code FMF
Combination Product (y/n)Y
PMA/PMN Number
K123766
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 09/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/30/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2019
Device Model NumberN/A
Device Catalogue Number185458
Device Lot NumberGVGG157-3
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/09/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/31/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/25/2017
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: 10/30/2018 Patient Sequence Number: 1
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