MAUDE Adverse Event Report: NOVO NORDISK A/S, MEDICAL SYSTEMS NOVOPEN 4; INSULIN DELIVERY DEVICE

Model Number N/A

Device Problem Defective Device (2588)

Patient Problems Hyperglycemia (1905); Diabetic Ketoacidosis (2364); Coma (2417)

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas).Suffered from hyperglycemia leaded to ketoacidosis and coma (patient is diabetic).[diabetic ketoacidotic hyperglycaemic coma].Novopen 4 issue [device issue].Hyperglycemia [hyperglycaemia].Case description: this serious spontaneous case from egypt was reported by a consumer as "suffered from hyperglycemia leaded to ketoacidosis and coma (patient is diabetic)(diabetic ketoacidotic hyperglycaemic coma)" with an unspecified onset date, "novopen 4 issue (device issue)" with an unspecified onset date, "suffered from hyperglycemia(hyperglycemia)" with an unspecified onset date, and concerned a 187 months old female patient who was treated with novopen 4 (insulin delivery device) from unknown start date and ongoing for "type 1 diabetes mellitus", novorapid penfill (insulin aspart) (dose, frequency & route used- 35 iu, qd (10u at breakfast -15u at lunch -10u at dinner), subcutaneous) from unknown start date and ongoing for "type 1 diabetes mellitus", tresiba penfill (insulin degludec) (dose, frequency & route used- 45 iu, qd (at 10 pm), subcutaneous) from unknown start date and ongoing for "type 1 diabetes mellitus", patient's height: 145 cm.Patient's weight: 65 kg.Patient's bmi: 30.91557670.Current condition: type 1 dm(9 years ago), hyperthyroidism.Concomitant products included - carbimazole, indral40mg (non codable).On unknown date patient shifted from tresiba flextouch to penfill when received it from (b)(6).On an unknown date from 9 years patient was using novo rapid penfills and from 7-8 months patient started using tresiba pen fills and still using on an unknown date patient was hospitalized for three days due to hyperglycemia which has lead to ketoacidosis and coma because of issues with novopen 4 patient does not knowif nn insulin was used during hospitalization period or not.On an unknown date patient random blood glucose (blood glucose) level was 300 mg/dl on an unknown date patient fasting blood glucose((blood glucose)) value was 250 mg/dl on an unknown date patient post prandial blood glucose((blood glucose)) was 350-400 mg/dl on an unknown date patient hba1c(glycosylated haemoglobin) was 11.1 % batch numbers: novopen 4: dvj1840.Novorapid penfill: nr7lk13.Tresiba penfill: ns6hp05.Action taken to novorapid penfill was not reported.Action taken to tresiba penfill was not reported.The outcome for the event "suffered from hyperglycemia leaded to ketoacidosis and coma (patient is diabetic)(diabetic ketoacidotic hyperglycaemic coma)" was recovered.The outcome for the event "novopen 4 issue (device issue)" was not reported.The outcome for the event "suffered from hyperglycemia(hyperglycemia)" was not yet recovered.Reporter comment: concomitant: indral 40mg (non codable).

Event Description

Case description: investigation result: name: novopen 4, batch number: dvj1840 no conclusion can be made without the sample or a valid batch number.The reported batch number was not valid.The number of complaints on the batch was evaluated and, when applicable, relevant actions were taken.The product was not returned for examination.Name: novorapid penfill 3 ml 100iu/ml, batch number: nr7lk13 the number of complaints on the batch was evaluated and, when applicable, relevant actions were taken.The product was not returned for examination.Name: tresiba penfill, batch number: ns6hp05 the number of complaints on the batch was evaluated and, when applicable, relevant actions were taken.The product was not returned for examination.Since last submission the case has been updated with the following: investigation results were updated.Annex b, c, d, g codes were updated.Narrative was updated accordingly.Final manufacturer's comment: (b)(6) 2024: the suspected device novopen 4 has not been returned to novo nordisk for evaluation.Batch number of the device unavailable despite repeated efforts to find the same (batch number is not valid).No batch trend analysis or reference sample analysis performed.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 4.Patient's underlying medical condition of type 1 diabetes mellitus is a significant confounding factor for the development of hyperglycaemia.Events are listed.This single case report is not considered to change the current knowledge of the safety profile of novorapid penfill and tresiba penfill.H3 continued: evaluation summary name: novopen 4, batch number: dvj1840 no conclusion can be made without the sample or a valid batch number.The reported batch number was not valid.The number of complaints on the batch was evaluated and, when applicable, relevant actions were taken.The product was not returned for examination.If possible, please forward the reported product(s) for further investigations.

• Brand Name: NOVOPEN 4
• 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: 18693964
• MDR Text Key: 335190515
• Report Number: 9681821-2024-00031
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• Reporter Country Code: EG
• PMA/PMN Number: 20-986N/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: 01/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2024
• 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: 185490
• Device Lot Number: DVJ1840
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/12/2024
• 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
• Treatment: CARBIMAZOLE (CARBIMAZOLE) ONGOING.
• Patient Outcome(s): Other; Hospitalization
• Patient Age: 15 YR
• Patient Sex: Female
• Patient Weight: 65 KG