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

Model Number	N/A
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	Elevated ketones/Diabetic Ketoacidosis (2364)
Date of Event	01/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Event verbatim [preferred term] (related symptoms if any separated by commas).Pen will dial to dose but nothing will dispense [device failure].Diabetic ketoacidosis with symptoms of high blood sugar reading of 600 mg/dl [diabetic ketoacidosis].Case description: this serious spontaneous case from the united states was reported by a consumer as "pen will dial to dose but nothing will dispense(device failure)" beginning on (b)(6) 2021, "diabetic ketoacidosis with symptoms of high blood sugar reading of 600 mg/dl(diabetic ketoacidosis)" beginning on (b)(6) 2021, and concerned a (b)(6) year-old male patient who was treated with novopen echo (insulin delivery device) from (b)(6) 2018 for "device therapy", novolog penfill (insulin aspart) solution for injection, 100 u/ml "dose, frequency & route used unk, subcutaneous" therapy dates (b)(6) 2018 to unk from (b)(6) 2018 for "drug use for unknown indication".Current condition: diabetes mellitus (type and duration not reported).Concomitant products included - lantus(insulin glargine).Treatment included - humalog(insulin lispro), potassium.On an unspecified date in (b)(6) 2021, the patient's novopen echo would dial but would not dispense the medication.On (b)(6) 2021, the patient experienced diabetic ketoacidosis with symptoms of high blood sugar reading of 600 mg/dl.On an unspecified date in (b)(6) 2021, the patient was hospitalized.The patient was treated with humalog and iv fluids including potassium at the hospital and was discharged.Batch numbers: novopen echo: fvga917.Novolog penfill: js69h79.Action taken to novopen echo was not reported.Action taken to novolog penfill was not reported.The outcome for the event "pen will dial to dose but nothing will dispense(device failure)" was not recovered.On (b)(6) 2021 the outcome for the event "diabetic ketoacidosis with symptoms of high blood sugar reading of 600 mg/dl(diabetic ketoacidosis)" was recovered.Preliminary manufacturer's comment: on (b)(6) 2021: the suspected device has not been returned to novo nordisk for evaluation.No conclusion is reached.
Event or Problem Description
Case description: investigational result: name: novopen echo ; batch :unknown.No investigation was possible, because neither sample nor batch number was available.Investigational results: name: novolog penfill 3 ml cartridges 100 units/ml (u-100).Batch js69h79.The product was not returned for examination.No abnormalities relating to the observed problem were found.The batch documentation has been reviewed and found to be normal.A reference sample check was found to be ok.Since last submission the case has been updated with the following: investigational results updated.B,c,d and g coded updated.Narrative updated accordingly.Final manufacturer's comment: 05-mar-2021: the suspected device (novopen echo) has not been returned to novo nordisk a/s for the investigation.The batch number was found to be in-valid.No batch trend analysis or reference sample examination performed.With the available limited information, it is therefore not possible to identify a clear root cause in relation to the functionality of novopen echo.However, young age of the patient with underlying diabetes mellitus is a significant confounding factor for the development of diabetic ketoacidosis.H3 continued: evaluation summary.Investigational result: name:novopen echo ; batch :unknown.No investigation was possible, because neither sample nor batch number was available.

• Brand Name: NOVOPEN ECHO
• Common Device Name: INSULIN DELIVERY DEVICE
• Manufacturer (Section D): NOVO NORDISK A/S, MEDICAL SYSTEMS; hilleroed, ; DA
• MDR Report Key: 11300689
• Report Number: 9681821-2021-00008
• Device Sequence Number: 3368717
• Product Code: FMF
• UDI-Device Identifier: 00301691854591
• UDI-Public: 00301691854591
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K123766
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2021

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/07/2016
• Device Model Number: N/A
• Device Catalogue Number: 185459
• Device Lot Number: FVGA917
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/18/2021
• Supplement Date Received by Manufacturer: 03/01/2021
• Initial Report FDA Received Date: 02/09/2021
• Supplement Report FDA Received Date: 03/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LANTUS (INSULIN GLARGINE)
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 10 YR