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

Model Number N/A

Device Problems Use of Incorrect Control/Treatment Settings (1126); No Display/Image (1183)

Patient Problem Hypoglycemia (1912)

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas) hypoglycemia of 30 mg/dl to 50 mg/dl [hypoglycaemia] display was not working [device information output issue] case description: this serious spontaneous case from brazil was reported by a consumer as "hypoglycemia of 30 mg/dl to 50 mg/dl(hypoglycemia)" with an unspecified onset date, "display was not working(device image display issue)" with an unspecified onset date, and concerned a female patient (born in 1985) who was treated with novopen echo (insulin delivery device) from unknown start date for "device therapy", novorapid penfill (insulin aspart) from unknown start date for "product used for unknown indication", patient's height, weight and body mass index (bmi) were not reported.Medical history was not provided.On an unknown date, the pen was not showing the dosages and due to it, patient's glycemia was not controlled, which reached 30 mg/dl to 50 mg/dl.Patient tried to adjusted the dosage to control the glycemia, but could not do it as the display was not working.The patient bought the pen in (b)(6) 2022 batch numbers: novopen echo: lvg3g67-9 novorapid penfill: requested action taken to novorapid penfill was not reported.The outcome for the event "hypoglycemia of 30 mg/dl to 50 mg/dl(hypoglycemia)" was not reported.The outcome for the event "display was not working(device image display issue)" was not reported.

Event Description

Case description: investigation results: name: novopen echo, batch number: lvg3g67-9.The product was not returned for examination.Name: novorapid penfill 3 ml - 100 u/ml, batch number: unknown.No investigation was possible, because neither sample nor batch number was available.Since last submission the following information was updated: investigation results updated.Imdrf codes added.Narrative has been updated accordingly.Final manufacturer's comment: 28-apr-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.H3 continued: evaluation summary.Name: novopen echo, batch number: lvg3g67-9.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: 16689170
• MDR Text Key: 312774850
• Report Number: 9681821-2023-00048
• 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,Followup
• Report Date: 03/16/2023

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: Lay User/Patient
• Device Expiration Date: 02/28/2023
• Device Model Number: N/A
• Device Catalogue Number: 185459
• Device Lot Number: LVG3G67-9
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/16/2023
• Initial Date FDA Received: 04/06/2023
• Supplement Dates Manufacturer Received: 04/24/2023
• Supplement Dates FDA Received: 05/19/2023
• 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): Other
• Patient Sex: Female