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

Model Number N/A

Device Problems Leak/Splash (1354); Unintended Movement (3026)

Patient Problem Hyperglycemia (1905)

Event Date 09/01/2020

Event Type  malfunction  

Event Description

High blood sugars blood glucose increased.Novopen echo is not working properly device malfunction.Novopen echo has dampness inside where cartridge was placed.Case description: this serious spontaneous case from the united states was reported by a consumer as "high blood sugars(blood sugar increased)" beginning on (b)(6) 2020, "novopen echo is not working properly(device malfunction)" beginning on (b)(6) 2020, "novopen echo has dampness inside where cartridge was placed(device component issue)" beginning on 01-sep-2020, and concerned a (b)(6) female patient who was treated with novopen echo (insulin delivery device) from unknown start date for "type 1 diabetes mellitus",novolog penfill (insulin aspart) from 1995 and ongoing for "type 1 diabetes mellitus", (regimen 1 dose and frequency: 14 - 15 units per day, regimen 2 dose and frequency: unk (dose increased) ).Current condition: (b)(6) (duration not reported).On (b)(6) 2020, the patient reported that novopen echo was not working properly and that there was dampness inside where the novolog cartridge was placed.As a result, the patient experienced high blood sugars of 417 mg/dl, 516 mg/dl.On an unspecified date in (b)(6) 2020, blood glucose got lowered to 275 mg/dl.Batch numbers: novopen echo: requested novolog penfill: ks6at64.Action taken to novopen echo was not reported.Action taken to novolog penfill was reported as dose increased.The outcome for the event "high blood sugars(blood sugar increased)" was not recovered.The outcome for the event "novopen echo is not working properly(device malfunction)" was not recovered.The outcome for the event "novopen echo has dampness inside where cartridge was placed(device component issue)" was not recovered.

Event Description

Case description: investigational results: name: novopen echo, batch number: unknown.No investigation was possible, because neither sample nor batch number was available.Name: novolog penfill 3 ml cartridges 100 units/ml (u-100), batch number: ks6at64 the product was not returned for examination.Since last submission the case has been updated with the following: investigation results updated.Annex b, c and d codes updated.Narrative updated accordingly.Final manufacturer comment: 13-oct-2020: the suspected device (novopen echo, batch number unknown) has not been returned to novo nordisk for evaluation.Batch number of device is not available, no batch trend analysis performed.Relevant information on product handling, needle usage and leaving needle attached to device between injections, product training are unavailable.With limited information regarding the handling of suspected device, it is not possible to identify a clear root-cause of the experienced adverse event and thus find similar incidents.Elderly age of the patient (75 years) and underlying type 1 diabetes mellitus are significant risk factors for the development of hypoglycaemia.H3 continued: evaluation summary: name: novopen echo, batch number: unknown.No investigation was possible, because neither sample nor batch number was available.

Event Description

Case description: case was previously captured with incorrect information for the field malfunction.On (b)(6) 2021, an amendment was performed.Since last submission, the following information has been amended: the field malfunction has been changed from "yes" to "no".

• 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
• Manufacturer Contact: p.o. box 846; plainsboro, NJ 08536 ; 8007276500
• MDR Report Key: 10618219
• MDR Text Key: 252823762
• Report Number: 9681821-2020-00042
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K123766
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2020
• 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: 10/09/2020
• 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): Other
• Patient Age: 75 YR
• Patient Sex: Female