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

Model Number N/A

Device Problems Improper or Incorrect Procedure or Method (2017); Defective Device (2588); Device Handling Problem (3265)

Patient Problem Diabetic Ketoacidosis (2364)

Event Date 05/01/2023

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas).Hyperglycemia and ketoacidosis coma [diabetic ketoacidotic hyperglycaemic coma].Device issue [device issue].Patient used the dialling clicks to estimate the dose of the product [wrong technique in product usage process].Needle attached to the pen in between injections [product storage error].Case description: this serious spontaneous case from egypt was reported by a consumer as "hyperglycemia and ketoacidosis coma(diabetic ketoacidotic hyperglycemic coma)" beginning on (b)(6) 2023, "device issue(device issue)" with an unspecified onset date, "patient used the dialling clicks to estimate the dose of the product(wrong technique in product usage process)" with an unspecified onset date, "needle attached to the pen in between injections(device stored with needle attached)" with an unspecified onset date, and concerned a 56 years old male patient who was treated with novopen 4 (insulin delivery device) from unknown start date for "device therapy", mixtard 30 hm penfill (insulin human, insulin isophane) (dose, frequency & route used- 65 iu, qd, subcutaneous) from 2008 to (b)(6) 2023 for "diabetes mellitus".Patient's height: 176 cm.Patient's weight: 82 kg.Patient's bmi: 26.47210740.Dosage regimens: novopen 4: mixtard 30 hm penfill: (b)(6) 2008 to (b)(6) 2023; current condition: rheumatoid, diabetes (before 2008) mellitus (type: not reported, since 2008).Concomitant products included - arthfree(leflunomide), kenacort [triamcinolone acetonide](triamcinolone acetonide) ongoing, methotrexate [methotrexate sodium](methotrexate sodium) ongoing.On an unknown date, patient complained that novopen 4 has an issue (not specified) and on (b)(6) 2023 patient experienced hyperglycemia and ketoacidosis coma due to this novopen 4 issue.Patient was hospitalized due to this event and was discharged after 8 days on ((b)(6) 2023).Patient in general reuse the needles and was advised to change the needle every one injection and not to be preserve it in between injection.Patient needle attached to the pen in between injections device stored with needle attached.The force needed to inject didn't feel different from normal, when the patient was using insulin suspension (cloudy insulin) he re-suspend (rolled it between your hands) before use.The patient used the dialing clicks to estimate the dose of the product.The needle to the pen was 180 degree angle (straight on), the insulin was stored at room temperature 20-25 degrees celsius.The patient didn't changed novopen , the cartridge holder didn't detach from the pen body accidentally or intentional before the event experienced.On an unknown date in (b)(6) 2023, patient's hba1c (glycosylated haemoglobin) was reported to be (b)(4).On an unknown date, patient's random blood sugar (blood glucose) was reported to be 119-190 mg/dl.Batch numbers: novopen 4: evg2002.Mixtard 30 hm penfill: was requested.Action taken to mixtard 30 hm penfill was reported as product discontinued.On (b)(6) 2023 the outcome for the event "hyperglycemia and ketoacidosis coma(diabetic ketoacidotic hyperglycemic coma)" was recovered.The outcome for the event "device issue(device issue)" was not yet recovered.The outcome for the event "patient used the dialling clicks to estimate the dose of the product(wrong technique in product usage process)" was not reported.The outcome for the event "needle attached to the pen in between injections(device stored with needle attached)" was not reported.References included: reference type: e2b linked report.Reference id#: (b)(4).Reference notes: same reporter/patient.Reference type: e2b linked report.Reference id#: (b)(4).Reference notes: same reporter/patient.Reference type: e2b linked report.Reference id#: (b)(4).Reference notes: same reporter/patient.Reference type: e2b company number.Reference id#: (b)(4).

Event Description

Case description: batch numbers: novopen 4: evg2002 (non valid) investigation results: novopen 4, batch number: evg2002 the reported batch number was not valid.No conclusion can be made without the sample or a valid batch number.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 for novopen 4 was updated.- imdrf codes (b, c, d, g) were updated.-narrative was updated accordingly.References included: reference type: e2b linked report reference id#: (b)(4) reference notes: same reporter/patient reference type: e2b linked report reference id#: (b)(4) reference notes: same reporter/patient reference type: e2b linked report reference id#: (b)(4) reference notes: same reporter/patient reference type: e2b company number reference id#: (b)(4) reference notes: reference type: mw 3500a mfr.Rpt.# reference id#: (b)(4) reference notes: medwatch 3500a mfr.Report number final manufacturer's comment: 18-jan-2024: the suspected device novopen 4 has not been returned to novo nordisk for evaluation.The reported batch number was not valid.No conclusion can be made without the sample or a valid batch number.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.Product handling error such as storing the device with needle attached, and using dialing click sound to estimate the dose can affect the functionality of device.Events are listed.This single case report is not considered to change the current knowledge of the safety profile of mixtard 30 penfill.H3 continued: evaluation summary novopen 4, batch number: evg2002 the reported batch number was not valid.No conclusion can be made without the sample or a valid batch number.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: 18343607
• MDR Text Key: 330665800
• Report Number: 9681821-2023-00172
• 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
• Report Date: 11/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2023
• 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: EVG2002
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/12/2024
• 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: ARTHFREE (LEFLUNOMIDE) ONGOING.; KENACORT [TRIAMCINOLONE ACETONIDE] (TRIAMCINOLONE.; METHOTREXATE [METHOTREXATE SODIUM].
• Patient Outcome(s): Hospitalization; Other; Life Threatening
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 82 KG