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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NOVO NORDISK A/S, MEDICAL SYSTEMS NOVOPEN 4 INSULIN DELIVERY DEVICE

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NOVO NORDISK A/S, MEDICAL SYSTEMS NOVOPEN 4 INSULIN DELIVERY DEVICE Back to Search Results
Model Number N/A
Device Problem Defective Device (2588)
Patient Problems Hyperglycemia (1905); Diabetic Ketoacidosis (2364)
Event Date 06/20/2021
Event Type  Injury  
Event Description
Increased acetone levels [blood ketone body increased]. Novopen 4 does not push insulin [device malfunction]. Study id: (b)(6): study description: trial title: main objective of the programme is to help patients to understand their diabetes and maintain normal life through qualified educators who offer simple and practical information directly to the patients and also, train patients on how to use their insulin devices and needles etc. The patient's height, weight and body mass index was not reported. This serious solicited report from (b)(6) was reported by a consumer as "increased glucose levels (blood sugar increased)" beginning on (b)(6) 2021, "increased acetone levels (acetone increased)" beginning on (b)(6) 2021, "novopen 4 does not push insulin(device malfunction)" beginning on (b)(6) 2021 and concerned a (b)(6) years old female patient who was treated with novopen 4 (insulin delivery device) from unknown start date for "type 1 diabetes", , novorapid penfill (insulin aspart) solution for injection, 100 iu/ml from unknown start date for "type 1 diabetes", dosage regimens: novopen 4: not reported. Novorapid penfill: not reported. Current condition: type 1 diabetes (duration not reported). Concomitant medications included - lantus(insulin glargine). It was reported that on (b)(6) 2021, novopen 4 did not push insulin, that lead to increased glucose and acetone levels and patient entered in intensive care unit (icu) on an unspecified date. Batch numbers: novopen 4: hvgl468. Novorapid penfill: asku; action taken to novopen 4 was reported as product discontinued due to ae. Action taken to novorapid penfill was not reported. On (b)(6) 2021 the outcome for the event "increased glucose levels(blood sugar increased)" was recovered. On (b)(6) 2021 the outcome for the event "increased acetone levels(acetone increased)" was recovered. The outcome for the event "novopen 4 does not push insulin(device malfunction)" was not reported. Reporter's causality (novopen 4) - increased glucose levels(blood sugar increased) : probable. Increased acetone levels(acetone increased) : probable. Novopen 4 does not push insulin(device malfunction) : probable. Company's causality (novopen 4) - increased glucose levels(blood sugar increased) : possible. Increased acetone levels(acetone increased) : possible. Novopen 4 does not push insulin(device malfunction) : possible. Reporter's causality (novorapid penfill) - increased glucose levels (blood sugar increased) : unlikely. Increased acetone levels(acetone increased) : unlikely. Novopen 4 does not push insulin(device malfunction) : unlikely. Company's causality (novorapid penfill) - increased glucose levels(blood sugar increased) : possible. Increased acetone levels(acetone increased) : possible. Novopen 4 does not push insulin(device malfunction) : possible. Preliminary manufacturer's comment: (b)(6) 2021: the suspected device (novopen 4) has not been returned to novo nordisk for evaluation. No conclusion is reached. Company comment: blood glucose increased and blood ketone bodies increased are assessed as listed according to the novo nordisk current ccds in novorapid penfill. Relevant information on acute infection, device and suspected product investigation results are unavailable for complete causality assessment. Patient's underlying medical condition of type 1 diabetes mellitus is a significant risk factor for the development of reported diabetic ketoacidosis. This single case report is not considered to change the current knowledge of the safety profile of novorapid penfill.
 
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Brand NameNOVOPEN 4
Type of DeviceINSULIN DELIVERY DEVICE
Manufacturer (Section D)
NOVO NORDISK A/S, MEDICAL SYSTEMS
hilleroed,,
DA
Manufacturer (Section G)
NOVO NORDISK A/S, MEDICAL SYSTEMS
brennum park
hilleroed,, 3400
DA 3400
Manufacturer Contact
p.o. box 846
plainsboro,, NJ 08536
8007276500
MDR Report Key12201671
MDR Text Key269799961
Report Number9681821-2021-00040
Device Sequence Number1
Product Code FMF
Combination Product (y/n)Y
Reporter Country CodeEG
PMA/PMN Number
20-986
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,study
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 07/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number185490
Device Lot NumberHVGL468
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/11/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/09/2021
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 07/21/2021 Patient Sequence Number: 1
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