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

Model Number N/A

Device Problems Defective Component (2292); Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas).Always in hospital [hospitalisation].Novopen not clicking into place [device malfunction].Faulty novopen echo plus's [device defective].Case description: this serious spontaneous case from the united kingdom was reported by a consumer as "always in hospital(hospitalization)" with an unspecified onset date, "novopen not clicking into place(device component malfunction)" with an unspecified onset date, "faulty novopen echo plus's(device defective)" with an unspecified onset date, and concerned a female patient who was treated with novopen echo plus (insulin delivery device) from unknown start date for "device therapy", patient's height, weight and body mass index was not reported.Procedure: device therapy.On an unknown date, the patient received faulty novopen echo plus, that were not clicking into place and she does not know why.Reported that always in a bad state (the novopen echo plus) and they were not good quality.On an unknown date, due to faulty pen, the patient was hospitalized.Patient thinks the hospital drop it as she was always in hospital and was thinking of coming off the pen.Batch numbers of novopen echo plus was not reported.Action taken to novopen echo plus was not reported.The outcome for the event "always in hospital(hospitalization)" was unknown.The outcome for the event "novopen not clicking into place (device component malfunction)" was not reported.The outcome for the event "faulty novopen echo plus's (device defective)" was not reported.No further information available."this report is for a foreign device that is assessed as "similar" to us marketed novopen echo".

Event Description

Case description: investigational result, novopen echo® plus - batch unknown no investigation was possible, because neither sample nor batch number was available.No further information available.Since last submission case was updated with following information investigational result updated , imdrf codes updated, narrative updated accordingly.Final manufacturer's comment: 17-mar-2023: the suspected device (novopen echo plus) has not been returned to novo nordisk a/s for the investigation.Batch number of device is not available, no batch trend analysis performed.Additionally clinical event experienced due to technical problem or malfunction with device is not available.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 plus.H3 continued: evaluation summary novopen echo® plus - batch unknown no investigation was possible, because neither sample nor batch number was available.

• Brand Name: NOVOPEN ECHO PLUS
• 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: 16451542
• MDR Text Key: 310329572
• Report Number: 9681821-2023-00026
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 02/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2023
• 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 Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/15/2023
• 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
• Patient Outcome(s): Hospitalization
• Patient Sex: Female