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); Failure to Deliver (2338); Unintended Movement (3026)

Patient Problems Hyperglycemia (1905); Loss of consciousness (2418)

Event Date 06/01/2022

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas).High blood glucose levels with loss of consciousness [hyperglycaemic unconsciousness].Dose counter reached to zero and then return back to 1 u [device issue].Dose injector sometimes doesn't inject insulin [device failure].Needle attached to the pen for 3 days [product storage error].The force needed to inject didn't feel different from normal [device use issue].The patient didn't re-suspend (rolled it between his hands) before use [product preparation error].Using dialling clicks to estimate the dose of the product [wrong technique in product usage process].Case description: this serious spontaneous case from egypt was reported by a consumer as "high blood glucose levels with loss of consciousness(hyperglycaemic unconsciousness)" beginning on jun-2022, "dose counter reached to zero and then return back to 1 u(device component issue)" with an unspecified onset date, "dose injector sometimes doesn't inject insulin(device failure)" with an unspecified onset date, "needle attached to the pen for 3 days(device stored with needle attached)" with an unspecified onset date, "the force needed to inject didn't feel different from normal(device use issue)" with an unspecified onset date, "the patient didn't re-suspend (rolled it between his hands) before use(product preparation error)" with an unspecified onset date, "using dialling clicks to estimate the dose of the product(wrong injection technique)" with an unspecified onset date, and concerned a adult patient who was treated with novopen 4 (insulin delivery device) from unknown start date for "diabetes mellitus", , mixtard 30 hm penfill (insulin human) from unknown start date for "diabetes mellitus", patient's height: 150 cm.Patient's weight: 65 kg.Patient's bmi: 28.88888890.Current condition: diabetes mellitus (type and duration not reported) historical condition: pulmonary artery distention.Concomitant products included lantus(insulin glargine).On an unknown date, the dose injector sometimes doesn't inject insulin.At the time of pen training piston rod moved normally when adjust the dose counter to 60u, she was asked to try new penfill and adjust the dose counter to 60u to make sure that piston rod touch the penfill but the dose counter reached to zero and then return back to 1 u automatically and she was asked to try new needle and adjust the dose counter to 4u and the insulin was injected normally but the dose counter return to 1 u automatically.On an unspecified date in (b)(6) 2022, patient had high blood glucose levels due to the reported technical complaint with loss of conscious and needed help, hospitalized for 4 days in icu but didn't know the exact treatments.It was reported that patient in general reuse the needles, attached to the pen in between injections (reported that kept novopen 4 in the fridge and change the needle after 3 days).The force needed to inject didn't feel different from normal it was also mentioned that the patient didn't re-suspend (rolled it between his hands) insulin suspension (cloudy insulin) before use and also dialling clicks to estimate the dose of the product the patient hasn't been trained by a health care professional in the use of the novopen, patient was the operator of the device at the time of the event.No recently changed your diet or exercise level.The needle to the pen in a 180-degree angle (straight on).The insulin in use preserved at room temperature 20-25 degrees celsius in morning and at refrigerator.Batch numbers: novopen 4: gvgh080.Mixtard 30 hm penfill: requested.Action taken to mixtard 30 hm penfill was not reported.On (b)(6) 2022 the outcome for the event "high blood glucose levels with loss of consciousness(hyperglycaemic unconsciousness)" was recovered.The outcome for the event "dose counter reached to zero and then return back to 1 u(device component issue)" was not reported.The outcome for the event "dose injector sometimes doesn't inject insulin(device failure)" was not reported.The outcome for the event "needle attached to the pen for 3 days(device stored with needle attached)" was not reported.The outcome for the event "the force needed to inject didn't feel different from normal(device use issue)" was not reported.The outcome for the event "the patient didn't re-suspend (rolled it between his hands) before use(product preparation error)" was not reported.The outcome for the event "using dialling clicks to estimate the dose of the product(wrong injection technique)" was not reported.Preliminary manufacturer's comment: 03-mar-2023: the suspected device novopen 4 has not been reported to novo nordisk for evaluation.No conclusion is reached.Incorrect handling of the product such as storing the device with needle attached between injections, product preparation error and using dialling clicks to measure insulin dosage can affect the functionality of devices.

Event Description

Case description: investigation result added.Novopen® 4, batch number: gvgh080.The product was not returned for examination.Mixtard® 30 penfill® 3 ml 100iu/ml, batch number: unknown.No investigation was possible, because neither sample nor batch number was available.Since last submission the following information has been updated: investigation result added.Imdrf code added.Narrative updated accordingly.Final manufacturer's comment: 24-apr-2023: the suspected device novopen 4 has not been reported to novo nordisk for investigation.The batch trend analysis and reference sample examination revealed nothing abnormal.No abnormalities relating to the observed problem were found.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.Incorrect handling of the product such as storing the device with needle attached between injections, product preparation error and using dialling clicks to measure insulin dosage can affect the functionality of devices.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: gvgh080.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: 16535922
• MDR Text Key: 311214059
• Report Number: 9681821-2023-00036
• 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: 12/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/21/2022
• Device Model Number: N/A
• Device Catalogue Number: 185490
• Device Lot Number: GVGH080
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2017
• 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: LANTUS (INSULIN GLARGINE).
• Patient Outcome(s): Hospitalization; Other
• Patient Weight: 65 KG