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

Model Number N/A

Device Problems No Display/Image (1183); Image Display Error/Artifact (1304)

Patient Problem Convulsion/Seizure (4406)

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas) patient experienced a seizure [seizure] novopen echoes displays failed [device information output issue] case description: this serious spontaneous case from australia was reported by a consumer as "patient experienced a seizure(seizure)" with an unspecified onset date, "novopen echoes displays failed(device image display 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", patient's height, weight and bmi(body mass index) were not reported.Medical history was not provided.On an unknown date, patient experienced seizure as their novopen echoes displays failed earlier than expected (approximately two years).The patient did not know when and how much their last dose was.Batch number of novopen echo was requested.The outcome for the event "patient experienced a seizure(seizure)" was recovered.The outcome for the event "novopen echoes displays failed(device image display issue)" was not reported.The event onset date is not reported in the case.However, the incident dates are captured to ensure the mir form is generated.

Event Description

Case description: investigation results: novopen echo - batch unknown.No investigation was possible, because neither sample nor batch number was available.Since last submission the case has been updated with the following: investigation results updated.Annex, b, c d and g codes added.Narrative has been updated accordingly.Final manufacturer's comment: (b)(6) 2024: the suspected device novopen echo has not been returned to novo nordisk for evaluation.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.Relevant information on medical confirmation, medical history, final diagnosis, treatment given, and outcome of the event seizure are unavailable for complete causality assessment.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: 18442378
• MDR Text Key: 331866031
• Report Number: 9681821-2024-00004
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 12/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/25/2024
• 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
• Patient Outcome(s): Other
• Patient Sex: Female