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

Model Number N/A

Device Problems Display or Visual Feedback Problem (1184); Inaccurate Delivery (2339)

Patient Problem Hypoglycemia (1912)

Event Date 07/28/2023

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas).Severe hypoglycemia [hypoglycaemia].Dose of 2.5 iu was selected and, after application, the dose display was indicating 29 iu [device information output issue].Incorrect dose was administered as 2.5 iu was selected but after application, the dose display was 29 iu [incorrect dose administered by device].Hypoglycemia [hypoglycaemia].Case description: this serious spontaneous case from brazil was reported by a patient family member or friend as "severe hypoglycemia(hypoglycemia)" beginning on (b)(6) 2023, "dose of 2.5 iu was selected and, after application, the dose display was indicating 29 iu (device image display issue)" beginning on (b)(6) 2023, "incorrect dose was administered as 2.5 iu was selected but after application, the dose display was 29 iu (incorrect dose administered by device)" beginning on (b)(6) 2023, " hypoglycemia(hypoglycemia)" beginning on (b)(6) 2023, and concerned a 6 years old female patient who was treated with novopen echo (insulin delivery device) from unknown start date and ongoing for "type 1 diabetes mellitus", fiasp (insulin aspart) (dose, frequency & route used-unk) from unknown start date and ongoing for "type 1 diabetes mellitus".Patient's height: 112 cm.Patient's weight: 22 kg.Patient's bmi: 17.53826530.Current condition: type 1 diabetes mellitus (duration not reported).It was reported that patient has been using the novopen echo device to apply the drug fiasp for about 1 year and a half.On (b)(6) 2023, a dose of 3 iu was selected and, after application, the dose display was indicating 8 iu, which led the patient to have hypoglycemia.On (b)(6) 2023, a dose of 2.5 iu was selected and, after application, the dose display was indicating 29 iu.The patient had severe hypoglycemia and had to spend the night in the hospital.The reporter confirms that the device was used according to the package leaflet, that was, using new needles for each application, storing the pen without a needle attached and keeping it under the indicated refrigeration conditions.However, she confirms that the flow test was not always performed before each application and that the device has already fallen at the beginning of use.Investigation result: name: novopen echo, batch number: lvg3g67.A batch record review on inaccurate dose was found to be normal.The number of complaints on the batch was evaluated and, when applicable, relevant actions were taken.The product was not returned for examination.Batch number of novopen echo: lvg3g67 and fiasp was not reported.Action taken to novopen echo was reported as no change.Action taken to fiasp was reported as no change.The outcome for the event " severe hypoglycemia(hypoglycemia)" was not reported.The outcome for the event "dose of 2.5 iu was selected and, after application, the dose display was indicating 29 iu (device image display issue)" was not reported.The outcome for the event "incorrect dose was administered as 2.5 iu was selected but after application, the dose display was 29 iu(incorrect dose administered by device)" was not reported.The outcome for the event "hypoglycemia(hypoglycemia)" was recovered.Final manufacturer's comment: (b)(6) 2023: the suspected device novopen echo has not been returned to novo nordisk for evaluation.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.Damage due to device fall could have contributed to incorrect dose delivered.H3 continued: evaluation summary.Name: novopen echo, batch number: lvg3g67.A batch record review on inaccurate dose was found to be normal.The number of complaints on the batch was evaluated and, when applicable, relevant actions were taken.The product was not returned for examination.

• 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: 17640081
• MDR Text Key: 322149703
• Report Number: 9681821-2023-00119
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• Reporter Country Code: BR
• 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
• Report Date: 07/31/2023

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: Other
• Device Expiration Date: 03/22/2023
• Device Model Number: N/A
• Device Catalogue Number: 185459
• Device Lot Number: LVG3G67
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/31/2023
• Initial Date FDA Received: 08/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2021
• 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): Hospitalization
• Patient Age: 6 YR
• Patient Sex: Female
• Patient Weight: 22 KG