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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NOVO NORDISK A/S NOVOPEN 3 JUNIOR INSULIN DELIVERY DEVICE

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NOVO NORDISK A/S NOVOPEN 3 JUNIOR INSULIN DELIVERY DEVICE Back to Search Results
Model Number N/A
Device Problem Device Inoperable (1663)
Patient Problem Diabetic Ketoacidosis (2364)
Event Date 07/07/2016
Event Type  Injury  
Event Description
Event verbatim [preferred term] (related symptoms if any separated by commas) diabetic ketoacidosis [diabetic ketoacidosis]. The pen wasn't letting any insulin come out [device issue]. She had a novorapid cartridge which had an air bubble in it [product quality issue]. This serious spontaneous case from the (b)(6) was reported by a consumer as "diabetic ketoacidosis" beginning on (b)(6) 2016, "the pen wasn't letting any insulin come out" with an unspecified onset date, and "she had a novorapid cartridge which had an air bubble in it" with an unspecified onset date, and concerned a (b)(6) years old female patient who was treated with novopen 3 junior (insulin delivery device) from unknown start date due to "type 1 diabetes mellitus", and novorapid penfill (insulin aspart) from unknown start date due to "type 1 diabetes mellitus". Patient's height, weight and body mass index were not reported. Medical history included type 1 diabetes, duration not reported. Concomitant products included - novorapid (insulin aspart) solution for injection, 100 u/ml. On an unknown date it was reported that the patient who was being treated with novorapid in a medtronic insulin pump and had a novopen junior and novorapid penfill when needed, noticed an air bubble in the cartridge and the pen wasn't letting any insulin come out. The patient stated that she did a test shot and the bubble came to the top but no insulin still came out. As a result she ended up in hospital for 2 days. The patient did not report any problems with the novorapid or the pump just stated that she had a problem with the novorapid penfill and novopen junior. On (b)(6) 2016 the patient was admitted and was diagnosed with diabetic ketoacidosis. The patient confirmed that she was all ok now and the hospital gave her new insulin. On (b)(6) 2016 the patient was discharged. Action taken to novorapid was not reported. Action taken to novopen 3 junior was not reported. On (b)(6) 2016 the outcome for the event "diabetic ketoacidosis" was recovered. The outcome for the event "the pen wasn't letting any insulin come out" was recovered. The outcome for the event "she had a novorapid cartridge which had an air bubble in it" was not reported. Company comment: the reported events are listed for novorapid product. This single case report is not considered to change the current knowledge of the safety profile of novorapid.
 
Event Description
Case description: investigation result: novorapidpenfill 3 ml. No investigation was possible, because neither sample nor batch number was available. Novopen junior. No investigation was possible, because neither sample nor batch number was available. Since last submission the following has been updated: investigation result, narrative. Company comment: the reported events are listed for novorapid product. This single case report is not considered to change the current knowledge of the safety profile of novorapid on 12-sep-2016: manufacturer final comment as the device novopen 3 junior has not been returned to novo nordisk a/s for investigation and only very limited information regarding the handling of suspected device is available, it is not possible to identify a clear root-cause of the experienced adverse event and thus not possible to find similar incidents to the one reported in argus (b)(4). Continued: evaluation summary novopen junior. No investigation was possible, because neither sample nor batch number was available.
 
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Brand NameNOVOPEN 3 JUNIOR
Type of DeviceINSULIN DELIVERY DEVICE
Manufacturer (Section D)
NOVO NORDISK A/S
bagsvaerd,
DA
Manufacturer (Section G)
NOVO NORDISK A/S, MEDICAL SYSTEMS
brennum park
hilleroed, 3400
DA 3400
Manufacturer Contact
novoprod novo nordisk inc.
p.o. box 846
plainsboro, NJ 08536
8007276500
MDR Report Key5921476
MDR Text Key53734913
Report Number9681821-2016-00028
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
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
Report Date 08/04/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/01/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number185258
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/17/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 09/01/2016 Patient Sequence Number: 1
Treatment
NOVORAPID (INSULIN ASPART) SOL FOR INJ 100 U/ML
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