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

Model Number N/A

Device Problems Inaccurate Delivery (2339); Device Displays Incorrect Message (2591)

Patient Problems Hypoglycemia (1912); Convulsion/Seizure (4406)

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas) severe hypoglycemia, resulting in a seizure [hypoglycaemic seizure] pen delivers too much insulin [device delivery system issue] pen shows a wrong bolus values in the display [device information output issue] case description: this serious spontaneous case from germany was reported by a patient family member or friend as "severe hypoglycemia, resulting in a seizure(hypoglycaemic seizure)" with an unspecified onset date, "pen delivers too much insulin(inaccurate delivery by device)" with an unspecified onset date, "pen shows a wrong bolus values in the display(device displays incorrect message)" with an unspecified onset date, and concerned a 8 years old female patient who was treated with novopen echo plus (insulin delivery device) from unknown start date for "type 1 diabetes mellitus".Patient's height, weight and body mass index (bmi) were not reported.Current condition : type 1 diabetes mellitus (duration not reported).On an unknown date, due to pen delivering too much insulin, the patient experienced a severe hypoglycemia which resulted in seizure.The emergency doctor was called, and the child was taken to the hospital and remained there for three days.It was reported that the reason for the seizure was due to the pen which shows a wrong bolus value in the display.The incident occurred shortly after the autumn vacations.Batch numbers: novopen echo plus: lvg5b82.The outcome for the event "severe hypoglycemia, resulting in a seizure(hypoglycaemic seizure)" was not reported.The outcome for the event "pen delivers too much insulin(inaccurate delivery by device)" was not reported.The outcome for the event "pen shows a wrong bolus values in the display(device displays incorrect message)" was not reported.References included: reference type: e2b company number.Reference id#:(b)(4).Reference notes:.

Event Description

Case description: investigation results: name: novopen echo plus, batch number: lvg5b82.The product was not returned for examination.Since last submission the case has been updated with the following: -investigation result updated.-annex b, c, d and g codes updated -narrative updated accordingly references included: reference type: e2b company number reference id#: (b)(4).Reference notes: final manufacturer's comment: 05-jul-2023: the suspected device novopen echo plus has not been returned to novo nordisk for investigation.No abnormalities relating to the observed problem were found in the reference sample analysis.The batch documentation has been reviewed and found to be normal.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.Patient is 8-year-old kid with history of type 1 diabetes mellitus, which is considered as confounding factors for the development hypoglycaemia and its complications.H3 continued: evaluation summary name: novopen echo plus, batch number: lvg5b82 the product was not returned for examination.

• 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: 17029355
• MDR Text Key: 316292956
• Report Number: 9681821-2023-00077
• 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,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 09/22/2023
• Device Model Number: N/A
• Device Catalogue Number: 185459
• Device Lot Number: LVG5B82
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2021
• 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): Required Intervention; Hospitalization
• Patient Age: 8 YR
• Patient Sex: Female