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

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.

• 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 Key: 13017166
• MDR Text Key: 288288507
• Report Number: 9681821-2021-00093
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: K123766
• Number of Events Reported: 1
• 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 Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2021
• Initial Date FDA Received: 12/16/2021
• Supplement Dates Manufacturer Received: 01/13/2022
• Supplement Dates FDA Received: 02/04/2022
• 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 Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR
• Patient Sex: Male