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

Model Number N/A

Device Problems Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017); Failure to Deliver (2338); Inaccurate Delivery (2339)

Patient Problem Hyperglycemia (1905)

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas).Diabetic foot [diabetic foot], suffered from hyperglycemia [hyperglycaemia], the pen was not inject the dose [device failure], pen didn't inject the accurate dose [device delivery system issue], dialling clicks used to estimate the dose of the product [wrong technique in product usage process], the insulin in use was refrigerated [product storage error].Case description: this serious spontaneous case from egypt was reported by a patient family member or friend as "diabetic foot(diabetic foot)" with an unspecified onset date, "suffered from hyperglycemia(hyperglycaemia)" with an unspecified onset date, "the pen was not inject the dose(device failure)" with an unspecified onset date, "pen didn't inject the accurate dose(inaccurate delivery by device)" with an unspecified onset date, "dialling clicks used to estimate the dose of the product(wrong technique in product usage process)" with an unspecified onset date, "the insulin in use was refrigerated(improper storage of product in use)" with an unspecified onset date, and concerned a male patient who was treated with novopen (insulin delivery device) from unknown start date for "diabetes mellitus", mixtard 30 hm penfill (insulin human) (dose, frequency & route used-unk) from unknown start date for "product used for unknown indication".Patient's height, weight and body mass index (bmi) were not reported.Current condition: diabetes (type and duration was not reported).On an unspecified date, the patient suffered from hyperglycemia, diabetic foot and had amputation for two fingers in his left foot.On an unspecified date, the pen was not injected the dose and was thinking of taking dose.During the use of novopen as the pen didn't inject the accurate dose.It was also reported that the patient was taking mixtard 30 penfills from more than 20 years and stopped it from a month and now using another type of insulin received from hi and lantus.The force needed to inject feel different from normal (lower/easier).The insulin used was suspension (cloudy insulin) and the patient re-suspend (rolled it between your hands) before use.The dialling clicks used to estimate the dose of the product as beginning of usage but now not used.The patient haven't recently changed any diet or exercise level.The needle attached to the pen in a 180 degree angle (straight on).The insulin was use didn't store at room temperature 20-25 degrees celsius, its preserved in refrigerator.The patient haven't recently changed from another novopen to the current novopen, he was using penfill with syringes.Before the experienced event occurred, the cartridge holder didn't detach from the pen body accidentally or intentional.After assembly the patient checked the insulin flow on an unknown date, the patient's hba1c (glycosylated haemoglobin) was 8.8 (unit not reported).On an unknown date, the patient's fbg (blood glucose) was 162 mg/dl.On an unknown date, the patient's ppbgl (blood glucose) was 110 mg/dl.Batch numbers: novopen: hvgl468 mixtard 30 hm penfill: mr7gt83 action taken to mixtard 30 hm penfill was not reported.The outcome for the event "diabetic foot(diabetic foot)" was not reported.The outcome for the event "suffered from hyperglycemia(hyperglycaemia)" was not reported.The outcome for the event "the pen was not inject the dose(device failure)" was not reported.The outcome for the event "pen didn't inject the accurate dose(inaccurate delivery by device)" was not reported.The outcome for the event "dialling clicks used to estimate the dose of the product(wrong technique in product usage process)" was not reported.The outcome for the event "the insulin in use was refrigerated(improper storage of product in use)" was not reported.Preliminary manufacturer's comment: 19-jul-2023: the relevant information on type of device name is unavailable.The suspected device has not been returned to novo nordisk for evaluation.No conclusion is reached.Company comment: diabetic foot is assessed as unlisted event, hyperglycaemia is assessed as listed event according to the novo nordisk current ccds in mixtard 30 penfill.Relevant information on medical history, prior glycaemic control, any history of trauma, duration of diabetes mellitus, action taken with mixtard 30 penfill, and outcome of the events are unavailable for complete causality assessment.This single case report is not considered to change the current knowledge of the safety of mixtard 30 penfill.References included: reference type: e2b company number reference id#: (b)(4) reference notes: reporter comment: the needle used and do the patient in general reuse the needles and didn't confirm either he used multi used needle or should he change it the customer was advised to inform the patient that the needle should be changed every one injection and another fu is scheduled to be done on patient's phone no as initially reporter at 3 pm as per reporter's request.The reporter enquired to call the patient directly as the tc persisted again and enquired for a help.

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas).Diabetic foot [diabetic foot] suffered from hyperglycemia [hyperglycaemia] the pen was not inject the dose [device failure] pen didn't inject the accurate dose [device delivery system issue] dialling clicks used to estimate the dose of the product [wrong technique in product usage process] the insulin in use was refrigerated [product storage error] the customer was complaining from leakage of insulin still persist [product leakage] case description: this serious spontaneous case from egypt was reported by a patient family member or friend as "diabetic foot(diabetic foot)" with an unspecified onset date, "suffered from hyperglycemia(hyperglycaemia)" with an unspecified onset date, "the pen was not inject the dose(device failure)" with an unspecified onset date, "pen didn't inject the accurate dose(inaccurate delivery by device)" with an unspecified onset date, "dialling clicks used to estimate the dose of the product(wrong technique in product usage process)" with an unspecified onset date, "the insulin in use was refrigerated(improper storage of product in use)" with an unspecified onset date, "the customer was complaining from leakage of insulin still persist(product leakage)" with an unspecified onset date, and concerned a male patient who was treated with novopen 4 (insulin delivery device) from unknown start date for "device theraphy", , mixtard 30 hm penfill (insulin human) from unknown start date for "product used for unknown indication".The customer was complaining from leakage of insulin still persist, due to technical issue in np4 and leakage of insulin the customer didn't take the dose so he suffered from hyperglycaemia and diabetic foot lead to amputation of two toes.The outcome for the event "the customer was complaining from leakage of insulin still persist(product leakage)" was not reported.Since last submission the case has been updated with the following - event product leakage was updated.- new annex a code added.- narrative was updated accordingly preliminary manufacturer's comment: 09-aug-2023: the suspected device (novopen 4) has not been returned to novo nordisk for evaluation.No conclusion is reached.In the initial evaluation, it was reported that device was stored in refrigerator, in which medication leaked, patient was not getting the required insulin and caused hyperglycaemia and its complications.Reporter comment: the patient didn't confirm either he used multi used needle or should he change it.The customer was advised to inform the patient that the needle should be changed every one injection and another fu is scheduled to be done on patient's phone no as initially reporter at 3 pm as per reporter's request.The reporter enquired to call the patient directly as the tc persisted again and enquired for a help.

Event Description

Case description: investigation result - name: novopen® 4, batch number: hvgl468 the number of complaints on the batch was evaluated and, when applicable, relevant actions were taken.The product was not returned for examination.Name: mixtard® 30 penfill® 3 ml 100iu/ml, batch number: mr7gt83 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 result updated -imdrf codes updated final manufacturer's comment: 30-aug-2023: the suspected device (novopen 4) has not been returned to novo nordisk for evaluation.No abnormalities relating to the observed problem were found in the reference sample analysis.The batch documentation has been reviewed and found to be normal.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.However, the device was stored in refrigerator, in which medication leaked, patient was not getting the required insulin and caused hyperglycaemia and its complications.Incorrect handling of the product could have contributed to reported events.H3 continued: evaluation summary name: novopen® 4, batch number: hvgl468 the number of complaints on the batch was evaluated and, when applicable, relevant actions were taken.The product was not returned for examination.

• 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: 17450872
• MDR Text Key: 320312292
• Report Number: 9681821-2023-00102
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• Reporter Country Code: EG
• PMA/PMN Number: 20-986
• 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,Followup
• Report Date: 07/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/26/2023
• Device Model Number: N/A
• Device Catalogue Number: 185490
• Device Lot Number: HVGL468
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2018
• 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): Required Intervention
• Patient Sex: Male