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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NOVO NORDISK A/S NOVOPEN 5 INSULIN DELIVERY DEVICE

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NOVO NORDISK A/S NOVOPEN 5 INSULIN DELIVERY DEVICE Back to Search Results
Model Number N/A
Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017); Defective Component (2292)
Patient Problems Hyperglycemia (1905); Diabetic Ketoacidosis (2364)
Event Date 01/31/2021
Event Type  Injury  
Event Description
Event verbatim [preferred term] (related symptoms if any separated by commas) ketones ranging from 0. 4-0. 9 [blood ketone body present], blood sugar levels hi [blood glucose increased], novopen 5 appears to be broken [device breakage], novopen 5 press on the plunger, they feel no resistance and that there appears to be a crack [device malfunction]. Case description: this serious spontaneous case from (b)(6) was reported by a nurse as "ketones ranging from 0. 4-0. 9(blood ketone body increased)" beginning on (b)(6) 2021, "blood sugar levels hi(blood sugar increased)" beginning on (b)(6) 2021, "novopen 5 appears to be broken(device breakage)" with an unspecified onset date, "novopen 5 press on the plunger, they feel no resistance and that there appears to be a crack(device component malfunction)" with an unspecified onset date, and concerned a (b)(6) years old female patient who was treated with novopen 5 (insulin delivery device) from unknown start date for "type 1 diabetes", novorapid penfill (insulin aspart) solution for injection, 100 u/ml, dose, frequency & route used 37 iu, qd (14 units breakfast, 12 units at lunch, 11 units at dinner), subcutaneous, additional dosage, regimens#2 increasing insulin dose, ongoing subcutaneous from unknown start date and ongoing for "type 1 diabetes". The patient height, weight and body mass index (bmi) details were not reported. Current condition: type 1 diabetes mellitus (since the patient was young), asperger syndrome, epilepsy. Concomitant products included - lantus(insulin glargine), lamictal(lamotrigine), keppra(levetiracetam) it was reported that, the patient used novopen 5 for approximately 2 years. The reporter has called from a residential care facility to report that novopen 5 that they are using for a patient appears to be broken. When they press on the plunger, they feel no resistance and that there appears to be a crack. The reporter also said that the piston rod appears wobbly. Since (b)(6) 2021 (sunday), the patient has had high blood sugars and ketones ranging from 0. 4 to 0. 9 (units not reported). The patient blood sugar levels have been registering high on the meter. They were increasing insulin dose to try and get it down. While it came down below high it was still registering higher than normal. They have changed out the insulin and pen into and today and on (b)(6) 2021 blood sugar levels were 10. 9 (units not reported). Batch number not available for novorapid penfill and novopen 5. Action taken to novorapid penfill was reported as no change. Action taken to novopen 5 was changed to a new novopen 5. On (b)(6) 2021 the outcome for the event "ketones ranging from 0. 4-0. 9(blood ketone body increased)" was recovered. On (b)(6) 2021 the outcome for the event "blood sugar levels hi(blood sugar increased)" was recovered. The outcome for the event "novopen 5 appears to be broken(device breakage)" was not reported. The outcome for the event "novopen 5 press on the plunger, they feel no resistance and that there appears to be a crack(device component malfunction)" was not reported. Preliminary manufacturer's comment: on (b)(6) 2021: the suspected device novopen 5 has not been returned to novo nordisk for evaluation. No conclusion is reached. Patient's underlying medical condition of type 1 diabetes mellitus is a significant confounding factor for the development of signs and symptoms of diabetic ketoacidosis. Company comment: blood ketone body present is assessed as unlisted; blood glucose increased is assessed as listed according to the novo nordisk current ccds in novorapid penfill. Relevant information on precipitating factors for diabetic ketoacidosis such as stress, trauma, surgery are unavailable. Patient's underlying medical condition of type 1 diabetes mellitus is a significant confounding factor for the development of signs and symptoms of diabetic ketoacidosis. This single case report is not considered to change the current knowledge of the safety profile of novorapid penfill. "this report is for a foreign device that is assessed as "similar" to us marketed novopen echo".
 
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Brand NameNOVOPEN 5
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
p.o. box 846
plainsboro, NJ 08536
8007276500
MDR Report Key11332095
MDR Text Key240596938
Report Number9681821-2021-00011
Device Sequence Number1
Product Code FMF
Combination Product (y/n)Y
Reporter Country CodeEI
PMA/PMN Number
K123766
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 02/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/13/2019
Device Model NumberN/A
Device Lot NumberGVGH328
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/02/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/27/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/13/2017
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: 02/16/2021 Patient Sequence Number: 1
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