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

Model Number N/A

Device Problems Device Handling Problem (3265); Incomplete or Inadequate Connection (4037)

Patient Problem Hyperglycemia (1905)

Event Type  Injury  

Event Description

Event: [preferred term] (related symptoms if any separated by commas).Had to go twice to the emergency room for hyperglycemia [hyperglycaemia].Smart pen did not have the plunger in contact with the cartridge [device delivery system issue].They did not know how to put it back in place to inject insulin [product communication issue].Case description: this serious spontaneous case from (b)(6) was reported by a consumer as "had to go twice to the emergency room for hyperglycemia(hyperglycemia)" with an unspecified onset date, "smart pen did not have the plunger in contact with the cartridge(device delivery system issue)" with an unspecified onset date, "they did not know how to put it back in place to inject insulin(product communication issue)" with an unspecified onset date, and concerned a patient who was treated with novopen echo plus (insulin delivery device) from unknown start date for "device therapy".Patient height, weight, body mass index were not reported.Dosage regimens: novopen echo plus: medical history was not provided.On unknown date patient was went to emergency room twice due to hyperglycemia and it was suspected that not taking insulin correctly.The smart pen did not have the plunger in contact with the cartridge, so the educator deduces that at some point the penfill was removed from the pen and they did not know how to put it back in place to inject insulin.Batch numbers: novopen echo plus: requested.Action taken to novopen echo plus was not reported.The outcome for the event "had to go twice to the emergency room for hyperglycemia(hyperglycemia)" was not reported.The outcome for the event "smart pen did not have the plunger in contact with the cartridge(device delivery system issue)" was not reported.The outcome for the event "they did not know how to put it back in place to inject insulin(product communication 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 result: novopen echo plus no investigation was possible, because neither sample nor batch number was available.Since last submission the case has been updated with the following: -final report updated.-further investigation updated.-corrective action updated.-imdrf codings updated.-investigation result updated.-narrative updated accordingly.Final manufacturer's comment: 06-jul-2023: the suspected device novopen echo plus 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 plus.Evaluation summary novopen echo plus 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: 17161288
• MDR Text Key: 317472449
• Report Number: 9681821-2023-00086
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 05/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2023
• 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: 07/03/2023
• 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