MAUDE Adverse Event Report: NOVO NORDISK A/S NOVOPEN 6; INSULIN DELIVERY DEVICE

Model Number N/A

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Hyperglycemia (1905)

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas), increased blood glucose values up to 500 mg/dl [hyperglycaemia], no insulin is delivered [device delivery system issue], display shows 'error' [device information output issue].Case description: this serious spontaneous case from germany was reported by a pharmacist as "increased blood glucose values up to 500 mg/dl(hyperglycemia)" with an unspecified onset date, "no insulin is delivered(failure of delivery by device)" with an unspecified onset date, "display shows 'error'(device image display issue)" with an unspecified onset date, and concerned a male patient (age not reported) who was treated with novopen 6 (insulin delivery device) from unknown start date for "device therapy", , novopen 6 (insulin delivery device) from unknown start date for "device therapy".The patient's height, weight and body mass index (bmi) were not reported.Dosage regimens: novopen 6.Medical history was not provided.On an unknown date, patient experienced increased in blood glucose values up to 500 mg/dl.Patient reported that with novopen 6 blue (batch: lvg4r79) no insulin was delivered and with novopen 6 silver (batch: lvg3e15) display showed 'error'.Batch numbers: novopen 6: lvg3e15, novopen 6: lvg4r79.Action taken to novopen 6 was not reported.Action taken to novopen 6 was not reported.The outcome for the event "increased blood glucose values up to 500 mg/dl(hyperglycemia)" was not reported.The outcome for the event "no insulin is delivered(failure of delivery by device)" was not reported.The outcome for the event "display shows 'error'(device image display issue)" was not reported.This report is for a foreign device that is assessed as "similar" to us marketed novopen echo.

Event Description

Case description: follow up received on 13-jul-2022: device available for evaluation was updated.Sample received date added.Narrative updated accordingly.References included: reference type: e2b company number.Reference id#: de-novoprod-927327.Reference type: mw 3500a mfr.Rpt.#.Reference id#: 9681821-2022-00051.Reference notes: medwatch 3500a mfr.Report number.Reference type: mw 3500a mfr.Rpt.#.Reference id#: 9681821-2022-00052.Reference notes: medwatch 3500a mfr.Report number.

Event Description

Case description: investigational results.Novopen 6 (lvg3e15-3): a visual examination of the returned product was performed.The memory display was blank and readout could not be initiated.The logs showed an interrupted dose which explains the customer's complaint that the pen showed an error.The interrupted dose was most likely due to a known fw bug triggering a false interrupted dose.Confirmed: the memory display showed "error" instead of showing the last injected dose size.The fault had no impact on the mechanical functions of the pen and was caused by an error in novo nordisk a/s.Visual examination and functional testing were performed.The device was tested with a random cartridge and a novo nordisk needle was mounted.During testing it was possible to deliver preparation from the cartridge.After functionally test it was possible to perform the readout.The electronic register was checked.No comment.The dose accuracy was measured by weighing using a random cartridge.The results were found to comply with specifications.Novopen 6 (lvg4r79-1): the electronic register was checked.No issues seen in the log function and accuracy test requested.The tests did not show any issues.The conclusion was a normal product.During examination of the product, no irregularities were detected.Visual examination and functional testing were performed.The device was tested with a random cartridge and a novo nordisk needle was mounted.During testing it was possible to deliver preparation from the cartridge.The dose accuracy was measured by weighing using a random cartridge.The results were found to comply with specifications.Since the last submission the case has been updated with the following information: investigation results were updated.Imdrf codes added.Narrative updated accordingly.Final manufacturer's comment: batch no.Lvg3e15-3: on 29-aug-2022: the suspected device novopen 6 has been returned to novo nordisk for evaluation.Upon investigation, memory display issue has been confirmed.However, the fault had no impact on the mechanical functions of the pen.The dose accuracy was measured by weighing using a random cartridge.The results were found to comply with specifications.With limited information regarding the handling of suspected device, it is not possible to identify a clear root-cause of the experienced adverse event of hyperglycaemia.Final manufacturer's comment: batch no:lvg4r79-1: 29-aug-2022: the suspected device novopen 6 has been returned to novo nordisk for evaluation.Since no faults were found on the returned device novopen 6 and only very limited information regarding the patients handling of the suspected device is reported in the case, it is not possible to elucidate a clear root cause for the experienced adverse event of hyperglycaemia.H3 continued: evaluation summary: novopen® 6, batch number:lvg4r79-1.A visual examination of the returned product was performed.The memory display was blank and readout could not be initiated.The logs show an interrupted dose which explains the customer's complaint that the pen shows an error.The interrupted dose was most likely due to a known fw bug triggering a false interrupted dose.Confirmed:the memory display shows "error" instead of showing the last injected dose size.The fault has no impact on the mechanical functions of the pen and is caused by an error in novo nordisk a/s.Visual examination and functional testing were performed.The device was tested with a random cartridge and a novo nordisk needle was mounted.During testing it was possible to deliver preparation from the cartridge.After functionally test it was possible to perform the readout.The electronic register was checked.No comment.The dose accuracy was measured by weighing using a random cartridge.The results were found to comply with specifications.Case forward to product responsible for conclusion.

• Brand Name: NOVOPEN 6
• Type of Device: INSULIN DELIVERY DEVICE
• Manufacturer (Section D): NOVO NORDISK A/S; bagsvaerd, ; DA
• Manufacturer (Section G): NOVO NORDISK A/S; krogshoejvej 55; bagsvaerd, 2880 ; DA 2880
• Manufacturer Contact: p.o. box 846; plainsboro, NJ 08536 ; 8007276500
• MDR Report Key: 14835093
• MDR Text Key: 295121480
• Report Number: 9681821-2022-00052
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K123766
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date: 06/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2023
• Device Model Number: N/A
• Device Lot Number: LVG3E15-3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/05/2021
• 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
• Patient Sex: Male