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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 Failure to Deliver (2338)
Patient Problems Diabetic Ketoacidosis (2364); Coma (2417)
Event Type  Injury  
Event Description
Event verbatim [preferred term] (related symptoms if any separated by commas) diabetic patient had coma because of ketoacidosis [diabetic ketoacidotic hyperglycaemic coma]. Novopen4 didn't push insulin for a week which led to coma because of ketoacidosis [device failure]. Case description: study id: (b)(4). Study description: 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 were not reported. This serious solicited report from egypt was reported by a consumer as "diabetic patient had coma because of ketoacidosis(diabetic ketoacidotic hyperglycaemic coma)" with an unspecified onset date , "novopen4 didn't push insulin for a week which led to coma because of ketoacidosis(device failure)" with an unspecified onset date and concerned a (b)(6) male patient who was treated with novopen 4 (insulin delivery device) from unknown start date for "diabetes mellitus", novopen 4 (insulin delivery device) from unknown start date for "diabetes mellitus", actrapid penfill (insulin human) solution for injection, 100 iu/ml (dose, frequency & route used - 13iu, subcutaneous) (therapy dates - ongoing) from unknown start date and ongoing for "diabetes mellitus", insulatard penfill (insulin human) suspension for injection, 100 iu/ml (dose, frequency & route used - 12 iu, subcutaneous) (therapy dates - ongoing) from unknown start date and ongoing for "diabetes mellitus". Current condition: diabetes mellitus (type and duration not reported). It was reported that novopen4 didn't push insulin for a week which led to coma because of ketoacidosis in a diabetic patient. The patient stopped using novopen 4. So patient used the syringe to take the dose instead of using novopen 4. Reporter was taught how to adjust the piston. It was reported that patient stopped using novopen4, 5 years ago and is just afraid of using it again. Batch numbers: novopen 4: cug2275. Novopen 4: cug2275. Actrapid penfill: gr78051; insulatard penfill: unknown; action taken to novopen 4 was product discontinued. Action taken to novopen 4 was product discontinued. Action taken to actrapid penfill was not reported. Action taken to insulatard penfill was not reported. The outcome for the event "diabetic patient had coma because of ketoacidosis(diabetic ketoacidotic hyperglycaemic coma)" was not reported. The outcome for the event "novopen4 didn't push insulin for a week which led to coma because of ketoacidosis(device failure)" was not reported. Reporter's causality (novopen 4) diabetic patient had coma because of ketoacidosis(diabetic ketoacidotic hyperglycaemic coma) : probable novopen4 didn't push insulin for a week which led to coma because of ketoacidosis(device failure) : probable. Company's causality (novopen 4) diabetic patient had coma because of ketoacidosis(diabetic ketoacidotic hyperglycaemic coma) : possible. Novopen4 didn't push insulin for a week which led to coma because of ketoacidosis(device failure) : possible. Reporter's causality (novopen 4) diabetic patient had coma because of ketoacidosis(diabetic ketoacidotic hyperglycaemic coma) : probable. Novopen4 didn't push insulin for a week which led to coma because of ketoacidosis(device failure) : probable. Company's causality (novopen 4) diabetic patient had coma because of ketoacidosis(diabetic ketoacidotic hyperglycaemic coma) : possible. Novopen4 didn't push insulin for a week which led to coma because of ketoacidosis(device failure) : possible. Reporter's causality (actrapid penfill) diabetic patient had coma because of ketoacidosis(diabetic ketoacidotic hyperglycaemic coma) : unlikely. Novopen4 didn't push insulin for a week which led to coma because of ketoacidosis(device failure) : unlikely. Company's causality (actrapid penfill) diabetic patient had coma because of ketoacidosis(diabetic ketoacidotic hyperglycaemic coma) : possible. Novopen4 didn't push insulin for a week which led to coma because of ketoacidosis(device failure) : possible. Reporter's causality (insulatard penfill) diabetic patient had coma because of ketoacidosis(diabetic ketoacidotic hyperglycaemic coma) : unlikely. Novopen4 didn't push insulin for a week which led to coma because of ketoacidosis(device failure) : unlikely. Company's causality (insulatard penfill) diabetic patient had coma because of ketoacidosis(diabetic ketoacidotic hyperglycaemic coma) : possible. Novopen4 didn't push insulin for a week which led to coma because of ketoacidosis(device failure) : possible. Investigation results name: novopen® 4 - batch cug2275. The product was not returned for examination. No investigation was possible, because sample was not available. Novopen 4, batch number: cug2275. The product was not returned for examination. If possible, please forward the reported product(s) for further investigations. Name: actrapid® penfill® 3 ml 100iu/ml - batch gr78051. The product was not returned for examination. No investigation was possible, because sample was not available. Name: insulatard® penfill® 3 ml 100iu/ml - batch unknown the product was not returned for examination. No investigation was possible, because neither sample nor batch number was available. In order to protect the safety of patient it will, in rare cases, be required to disassemble the medical device immediately in a way where it is not subsequently possible to reassemble it (e. G. Destructive testing or altering of the medical device). The disassembled medical device will be stored with the same retention period as other complaint samples. On (b)(6) 2021, a correction had been performed. It was reported that patient used 2 "novopen 4" pens with the same batch number. Hence additional novopen 4 had been added as a suspect device which was missed to be captured in the initial case and resubmitted. Final manufacturer's comment: (b)(6) 2021: the suspected device novopen 4 has not been returned to novo nordisk for evaluation. Considering that reporter was taught how to adjust the piston, device failure could be related to product training issues. With limited information regarding the handling of suspected device, it is not possible to identify a clear root-cause of the experienced adverse event. Patient's underlying medical condition of type 1 diabetes mellitus is a significant confounding factor for the development of diabetic ketoacidosis. Company comment: diabetic ketoacidotic hyperglycaemia coma is assessed as listed according to the novo nordisk current ccds in actrapid and insulatard. Patient's age ((b)(6)), underlying type 1 diabetes mellitus and wrong technique in product usage process are significant confounding factors for the development of diabetic ketoacidotic hyperglycaemic coma. This single case report is not considered to change the current knowledge of the safety profile of actrapid and insulatard. References included: reference type: e2b company number. Reference id#: (b)(4). Reference notes: reference type: (b)(4). Reference id#: (b)(4). Reference notes: medwatch 3500a mfr. Report number continued: evaluation summary investigation result: name: novopen 4, batch number: cug2275 the product was not returned for examination. If possible, please forward the reported product(s) for further investigations.
 
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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 Key12193918
MDR Text Key268074192
Report Number9681821-2021-00037
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
Type of Report Initial
Report Date 01/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2015
Device Model NumberN/A
Device Catalogue Number185490
Device Lot NumberCUG2275
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/23/2021
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 07/19/2021 Patient Sequence Number: 1
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