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

Model Number N/A

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Hyperglycemia (1905)

Event Date 12/27/2022

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas) hyperglycaemia [hyperglycaemia].The dial showed 0 after administraion of novorapid at 5iu right before lunch.However, the memory display showed "end".[device information output issue].Case description: this serious spontaneous case from japan was reported by a consumer as "hyperglycaemia(hyperglycaemia)" beginning on (b)(6) 2022, "the dial showed 0 after administraion of novorapid at 5iu right before lunch.However, the memory display showed "end".(device information output issue)" with an unspecified onset date, and concerned a female patient who was treated with novopen echo (insulin delivery device) from unknown start date for "device therapy", , novorapid chu penfill (insulin aspart) solution for injection, 100 iu/ml (dose, frequency & route used - unk, subcutaneous) from unknown start date for "drug use for unknown indication", patient's height, weight and body mass index was not reported.Dosage regimens: novopen echo: novorapid chu penfill: not reported to not reported, 27-dec-2022 to not reported, not reported to not reported; medical history was not provided.Concomitant products included - tresiba chu penfill(insulin degludec) solution for injection, 100 iu/ml, novopen echo(insulin delivery device) n/a on (b)(6) 2022 the dial showed 0 after administraion of novorapid at 5iu right before lunch.However, the memory display showed "end".Patient did not remember such as whether she dropped novopen echo (red color).The date red color of novopen echo was given to her was unknown.Thereafter, there was an unfortunate incident around her.She spent different days from usual and was in stimulated condition.On the same date, her blood sugar level was 539 mg/dl when measuring it a little past 5:00 pm.When she set the units of novorapid at 2iu and pushed the infusion button of novopen echo (blue color) which was used for tresiba, the memory display showed "2".She commented that injection had not been performed successfully due to the error of novopen echo (red color).Batch numbers: novorapid chu penfill and novopen ech was requested.Action taken to novopen echo was not reported.Action taken to novorapid chu penfill was reported as unknown.The outcome for the event "hyperglycaemia(hyperglycaemia)" was unknown.The outcome for the event "the dial showed 0 after administraion of novorapid at 5iu right before lunch.However, the memory display showed "end".(device information output issue)" was not reported.In order to protect the safety of patient it will, in rare cases, be required to disassemble the medical device immediately in a way where it is not subsequently possible to reassemble it (e.G.Destructive testing or altering of the medical device).The disassembled medical device will be stored with the same retention period as other complaint samples.Preliminary manufacturer comment: (b)(6) 2023: the suspected device novopen echo has not been returned to novo nordisk yet to evaluate if it works according to set specification and intended use.With very limited information regarding handling of the suspected device reported, dropping the device in the case, it is not possible to elucidate a clear root cause for the experienced adverse event of hyperglycaemia.Additional dosage regimens: suspect product 2.Dose, frequency & route used 3.Therapy dates (if unknown, give duration) 6.Lot # 7.Exp.Date.#1 novorapid chu penfill regimen # 2 5iu right before lunch., subcutaneous (b)(6) 2022 to unk #1 novorapid chu penfill regimen # 3 2iu, subcutaneous.

Event Description

Case description: investigational result: novorapid chu penfill - batch unknown no investigation was possible, because neither sample nor batch number was available.Novopen echo- batch unknown no investigation was possible, because neither sample nor batch number was available.Final manufacturer comment: 02-mar-2023: the suspected device novopen echo has not been returned to novo nordisk for investigation.Batch number of the device unavailable despite repeated efforts to find the same.No batch trend analysis or reference sample analysis performed.No other confounding factors identified.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 echo.It was reported that memory display showed "end".That means, the device battery has been expired.The user can detect that the display does not work as intended; however, the pen can still be used to deliver the needed insulin.It is estimated that the fault has no impact on the patient's health or treatment.H3 continued: evaluation summary novopen echo- batch unknown no investigation was possible, because neither sample nor batch number was available.

• Brand Name: NOVOPEN ECHO
• Type of Device: INSULIN DELIVERY DEVICE
• Manufacturer (Section D): NOVO NORDISK A/S, MEDICAL SYSTEMS; hilleroed, ; 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: 16134584
• MDR Text Key: 307061447
• Report Number: 9681821-2023-00007
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: K123766
• 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: 12/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 185459
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/27/2022
• Initial Date FDA Received: 01/10/2023
• Supplement Dates Manufacturer Received: 02/21/2023
• Supplement Dates FDA Received: 03/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: NOVOPEN ECHO (INSULIN DELIVERY DEVICE); TRESIBA CHU PENFILL (INSULIN DEGLUDEC)
• Patient Outcome(s): Other
• Patient Sex: Female