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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 Problem Device Handling Problem (3265)
Patient Problem Injection Site Reaction (4562)
Event Date 11/15/2021
Event Type  Injury  
Event Description
Event verbatim [preferred term] (related symptoms if any separated by commas).Injection site was pain [injection site pain].Injection site was pain, with a strong tingling sensation.[injection site paraesthesia].Device issue [device issue].Case description: this serious spontaneous regulatory authority case received via nmpa (national medical products administration), china from china was reported by a health care professional nos as "injection site was pain(injection site pain)" beginning on (b)(6) 2021, "injection site was pain, with a strong tingling sensation.(injection site tingling)" beginning on (b)(6)2021, "device issue(device issue)" beginning on (b)(6) 2021, and concerned a (b)(6) male patient who was treated with novopen 5 (insulin delivery device) from (b)(6) 2021 for "type 2 diabetes mellitus", , novomix 30 (insulin aspart) (dose, frequency & route used-unk, unknown) from unknown start date for "type 2 diabetes mellitus".Patient's height, weight and body mass index (bmi) were not reported.Dosage regimens: novopen 5: (b)(6) 2021 to not reported; novomix 30: unknown.Current condition: type 2 diabetes mellitus(duration not reported), hypertension, aseptic osteonecrosis of the right femoral head.On (b)(6) 2021,the patient went to our hospital for surgical treatment due to aseptic osteonecrosis of the right femoral head.According to the doctor's prescription, the patient needed to be injected insulin aspart 30r for two days to stabilized the blood glucose in the normal range before surgery hence started using novopen 5.On (b)(6) 2021, when using an pen to inject novomix 30 for the patient, the clinical manifestation of the injection site was pain, with a strong tingling sensation.On physical examination, the blood pressure was normal, the heart rate was normal, and the consciousness was clear.There was allegation of device failure.Batch numbers: novopen 5: requested.Novomix 30: requested.Action taken to novopen 5 was reported as product discontinued.Action taken to novomix 30 was reported as product discontinued.The outcome for the event "injection site was pain(injection site pain)" was recovering/resolving.The outcome for the event "injection site was pain, with a strong tingling sensation.(injection site tingling)" was recovering/resolving.The outcome for the event "device issue (device issue)" was not reported.References included: reference type: (b)(4) authority number.Reference id#: (b)(4).Reference notes: nmpa (national medical products administration), (b)(4).This report includes a foreign device (novopen 5) that is assessed as "similar" to us marketed novopen echo.Reporter comment: batch number reported as lug2k60-1(non validated).
 
Event Description
Investigation results : name: novopen 5, batch number: lug2k60-1.The product was not returned for examination.If possible, please forward the reported product(s) for further investigations.Name: novomix 30, batch number: unknown.No investigation was possible, because neither sample nor batch number was available.If possible, please forward the reported product(s) for further investigations.Since last submission the following has been updated: - inv result updated.-tabs, malfunction and is non-reportable updated.- annex b, c, d and g codes were added.Narrative updated accordingly.Final manufacturer's comment: the suspected device novopen 5 has not been returned to novo nordisk.Since batch number is not validated, batch trend analysis or reference sample analysis was not performed.With limited information regarding the patient's handling of the suspected device reported in the case, it is not possible to elucidate a clear root cause in relation to functionality of novopen 5.Patient's elderly age group is assessed as risk factor for the development injection site reaction reported.Injection site reactions are listed.This single case report is not considered to change the current knowledge of the safety profile of novomix 30.This report includes a foreign device (novopen 5) that is assessed as "similar" to us marketed novopen echo.H3 continued: evaluation summary: name: novopen® 5, batch number: lug2k60-1.The product was not returned for examination.If possible, please forward the reported product(s) for further investigations.
 
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Brand Name
NOVOPEN 5
Type of Device
INSULIN 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 Key13017166
MDR Text Key288288507
Report Number9681821-2021-00093
Device Sequence Number1
Product Code FMF
Combination Product (y/n)Y
Reporter Country CodeCH
PMA/PMN Number
K123766
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Model NumberN/A
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/30/2021
Initial Date FDA Received12/16/2021
Supplement Dates Manufacturer Received01/13/2022
Supplement Dates FDA Received02/04/2022
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 Sequence Number1
Patient Outcome(s) Other;
Patient Age67 YR
Patient SexMale
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