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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NOVO NORDISK A/S, MEDICAL SYSTEMS NOVOPEN 3; INSULIN DELIVERY DEVICE
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NOVO NORDISK A/S, MEDICAL SYSTEMS NOVOPEN 3; INSULIN DELIVERY DEVICE Back to Search Results
Model Number N/A
Device Problem Failure to Deliver (2338)
Patient Problem Diabetic Ketoacidosis (2364)
Event Type  Injury  
Event Description
Event verbatim: diabetic ketoacidosis; device which wasn't firing; device failure.Case description: this serious spontaneous case from the (b)(6) was reported by a consumer as "diabetic ketoacidosis (diabetic ketoacidosis)" with an unspecified onset date, "device which wasn't firing(device failure)" with an unspecified onset date, and concerned a female patient who was treated with novopen (insulin delivery device) from unknown start date for "type 1 diabetes mellitus" and insulin (non -codable) from unknown start date for "type 1 diabetes mellitus".The patient's height, weight and body mass index were not reported.Current condition: type 1 diabetes (since 31 years).On an unknown date 12-15 years ago it was reported that the device wasn't firing which resulted the patient ending up in hospital as they developed diabetic ketoacidosis (dka).Caller was unsure of the name of the device, but it mentioned device was withdrawn 6 months later.The batch number was requested.Action taken to novopen was not reported.Action taken to insulin was not reported.The outcome for the event, "diabetic ketoacidosis(diabetic ketoacidosis)", was not reported.The outcome for the event ,"device which wasn't firing(device failure)", was not reported.Preliminary manufacturer's comment: the suspected device (novopen) has not been returned to novo nordisk for evaluation.No conclusion has been reached.Patient's underlying medical condition of type 1 diabetes mellitus is a significant confounding factor for the development of diabetic ketoacidosis.
 
Event Description
Case description: this serious spontaneous case from the united kingdom was reported by a consumer as "diabetic ketoacidosis(diabetic ketoacidosis)" with an unspecified onset date, "device which wasn't firing(device failure)" with an unspecified onset date, and concerned a adult female patient who was treated with novorapid (insulin aspart) solution for injection, 100 u/ml (dose, frequency & route used - unk, unknown) from unknown start date for "type 1 diabetes", , novopen (insulin delivery device) from unknown start date for "type 1 diabetes mellitus".It was the device withdrawn from the market in summer of that year.It was without doubt the reason for diabetic ketoacidosis and a spoilt christmas this year.Action taken to novorapid was not reported.If the sample is received, the device will be investigated to evaluate it works according to the set specifications and intended use.
 
Event Description
Case description: this serious spontaneous case from the united kingdom was reported by a consumer as "diabetic ketoacidosis(diabetic ketoacidosis)" with an unspecified onset date, "device which wasn't firing(device failure)" with an unspecified onset date, and concerned a adult female patient (age was not reported) who was treated with novorapid (insulin aspart) from unknown start date for "type 1 diabetes", , novopen 3 (insulin delivery device) from unknown start date for "type 1 diabetes mellitus".Batch number of novorapid and novopen 3 has been requested.Action taken to novopen 3 was not reported.Investigation results: novorapid- batch unknown.No investigation was possible, because neither sample nor batch number was available.Novopen 3 - batch unknown.No investigation was possible, because neither sample nor batch number was available.Since last submission the following has been updated: -suspect product updated to novopen 3.-investigation results added.-b,c,d,g codes updated.-narrative updated accordingly.Final manufacturer's comment: 03-feb-2021: the suspected device novopen 3 has not been returned to novo nordisk for evaluation.Batch number of device is not available, no batch trend analysis performed.With limited information regarding the handling of suspected device, it is not possible to identify a clear root-cause of the experienced adverse events.Patient's underlying medical condition of type 1 diabetes mellitus is a significant confounding factor for the development of diabetic ketoacidosis.H3 continued: evaluation summary: investigation results: novopen 3 - batch unknown.No investigation was possible, because neither sample nor batch number was available.
 
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Brand Name
NOVOPEN 3
Type of Device
INSULIN DELIVERY DEVICE
Manufacturer (Section D)
NOVO NORDISK A/S, MEDICAL SYSTEMS
hilleroed,
DA 
MDR Report Key11023150
MDR Text Key222290732
Report Number9681821-2020-00062
Device Sequence Number1
Product Code FMF
Combination Product (y/n)Y
PMA/PMN Number
19-938
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Type of Report Initial,Followup,Followup
Report Date 12/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberN/A
Device Catalogue Number185290
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received01/29/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
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