MAUDE Adverse Event Report: NOVO NORDISK A/S, MEDICAL SYSTEMS NOVOPEN 3; INSULIN DELIVERY DEVICE

Model Number N/A

Device Problem Defective Device (2588)

Patient Problems Cataract (1766); Hyperglycemia (1905); Hypoglycemia (1912)

Event Date 02/21/2024

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas); the blood glucose was measured at 10 mmol/l [blood glucose increased]; the patient needed to have a cataract operation [cataract operation]; the patient needed to have a cataract operation [cataract operation]; fundus lesions [eye disorder]; suspected novopen issue [device issue]; hypoglycemic symptoms [hypoglycaemia]; case description: this serious spontaneous case from china was reported by a consumer as "the blood glucose was measured at 10 mmol/l(blood glucose increased)" beginning on (b)(6) 2024, "the patient needed to have a cataract operation(cataract operation)" with an unspecified onset date, "the patient needed to have a cataract operation(cataract operation)" beginning on (b)(6) 2024, "fundus lesions (eye disorder)" with an unspecified onset date, "suspected novopen issue(device issue)" with an unspecified onset date, "hypoglycemic symptoms(hypoglycaemia)" with an unspecified onset date, and concerned a 66 years old female patient who was treated with novopen 3 (insulin delivery device) from unknown start date for "type 2 diabetes mellitus", novomix 30 (insulin aspart, insulin aspart protamine) (dose, frequency & route used: 28 iu, qd (14 u in the morning and 14 u in the evening and regimen #2: 30 iu, qd (14 iu in the morning and 16 iu in the evening ongoing))) from unknown start date and ongoing for "type 2 diabetes mellitus".Patient's height: 155 cm; patient's weight: 45 kg; patient's bmi: 18.73048910.Patient's height: 155 cm; patient's weight: 45 kg ; patient's bmi: 18.73048910.; current condition: type 2 diabetes mellitus (diagnosed in 2008 at a local hospital).On an unknown date, the patient's daily fasting blood glucose (blood glucose) was 5 mmol/l.On an unknown date, the patient had fundus lesions.On an unknown date, the patient suspected novopen issues.Cataracts occurred in the recent 5-6 years on (b)(6) 2024, patient was admitted to the hospital, and on an unknown date patient had cataract operation.Patient was discharged on (b)(6) 2024.On (b)(6) 2024,the patient went to the hospital and got admitted , on (b)(6) 2024 patient had a cataract operation.Patient was discharged on the same date ((b)(6) 2024).The blood glucose (blood glucose) at 10:00 am was measured at 10 mmol/l.The doctor said that the blood glucose was not controlled well.Needle was single used, installed vertically and it was removed after injection.Novomix 30 was resuspended by rolling it between the hands and it was stored at room temperature.The patient suspected novopen issue before the second hospitalization.Fundus lesions also worsened during the second hospitalization.After the second hospitalization, the patient changed from novopen 3 to the novopen 5.Batch numbers: novopen: requested, novomix 30: requested, action taken to novopen 3 was not reported.Action taken to novomix 30 was not reported.The outcome for the event "the blood glucose was measured at 10 mmol/l(blood glucose increased)" was not reported.The outcome for the event "the patient needed to have a cataract operation(cataract operation)" was not reported.The outcome for the event "the patient needed to have a cataract operation(cataract operation)" was not reported.The outcome for the event "fundus lesions(eye disorder)" was not reported.The outcome for the event "suspected novopen issue(device issue)" was not reported.The outcome for the event "hypoglycemic symptoms(hypoglycaemia)" was recovered.Company comment: cataract operation, fundus lesion are assessed as unlisted events; blood glucose increased is assessed as listed event according to the novo nordisk current ccds in novomix 30.With the available limited information, elderly age of the patient, long standing type 2 diabetes mellitus are significant confounding factors for the development of fundus lesion and cataract (chronic micro-vascular complications of diabetes).The suspected faulty device has not been returned to novo nordisk for evaluation, no conclusion reached regarding the device malfunction leading to increased blood glucose.This single case report is not considered to change the current knowledge of the safety profile of novomix 30.References included: reference type: e2b company number, reference id#: (b)(4).Reference notes:.

Event Description

Investigation results: name: novopen 3, batch number: unknown.No investigation was possible, because neither sample nor batch number was available.Name: novomix 30, batch number: unknown.No investigation was possible, because neither sample nor batch number was available.Since last submission, the case has been updated with the following: device tab updated, investigation results updated, final report ticked in eu/ca tab, b,c,d,g coded added in device addendum tab, and narrative updated accordingly.Final manufacturer's comment: 22-apr-2024: the suspected device (novopen 3) has not been returned to novo nordisk a/s for the investigation.Batch number of device is not available, no batch trend analysis performed.No reference sample analysis done.No other confounding factors identified.With the available limited information regarding the handling of the suspected device, it is not possible to identify a clear root cause in relation to functionality of novopen 3.H3 continued: evaluation summary: name: novopen 3, batch number: unknown.No investigation was possible, because neither sample nor batch number was available.

• Brand Name: NOVOPEN 3
• Type of Device: INSULIN 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 Key: 18920974
• MDR Text Key: 337866032
• Report Number: 9681821-2024-00043
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: 19-938N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 185290
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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; Hospitalization
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 45 KG