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

Model Number	N/A
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Elevated ketones/Diabetic Ketoacidosis (2364)
Date of Event	03/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Event verbatim [preferred term] (related symptoms if any separated by commas) mild diabetic ketoacidosis with high blood sugar readings in the 300s mg/dl two consecutive nights [diabetic ketoacidosis] novopen echo was malfunctioning [device malfunction].Case description: this serious spontaneous case from the united states was reported by a consumer as "dka with high blood sugar readings in the 300s mg/dl two consecutive nights (diabetic ketoacidosis)" beginning on (b)(6) 2021, "novopen echo was malfunctioning (device malfunction)" beginning on (b)(6) 2021, and concerned an adult female patient who was treated with novopen echo (insulin delivery device) from unknown start date for "type 1 diabetes mellitus", , novolog penfill (insulin aspart) solution for injection, 100 u/ml (dose, frequency & route used - unk, unknown) from unknown start date for "drug use for unknown indication", current condition: type 1 diabetes mellitus (since (b)(6) 2020).On an unknown date of (b)(6) 2021, the patient experienced that novopen echo was malfunctioning and as a result the patient experienced a mild diabetic ketoacidosis with symptom of dizziness and high blood sugar readings in the 300's mg/dl two consecutive nights.It was reported that patient does not want to use the novopen echo ever again.Patient does not feel safe using the novo pen echo.Batch numbers: novopen echo: kvg0m24-3, novolog penfill: ks6ca00.Action taken to novopen echo was reported as product discontinued.Action taken to novolog penfill was not reported.The outcome for the event "dka with high blood sugar readings in the 300s mg/dl two consecutive nights(diabetic ketoacidosis)" was recovering/resolving.The outcome for the event "novopen echo was malfunctioning(device malfunction)" was not reported.Preliminary manufacturer's comment: (b)(6) 2021: the suspected device novopen echo has not been returned to novo nordisk for evaluation.No conclusion is reached.
Event or Problem Description
Case description: investigation result: name: novopen echo - batch kvg0m24-3 the product was not returned for examination.The batch documentation was reviewed.No abnormalities relating to the observed problem were found.The batch documentation has been reviewed and found to be normal.Name: novolog penfill 3 ml cartridges 100 units/ml (u-100) - batch ks6ca00 the product was not returned for examination.A reference sample was examined macroscopically and analysed chemically.The reference sample was found to be normal.The results were found to comply with specifications.During investigation no irregularities related to the complaint was detected on a reference/reserve sample of the batch in question.Since last submission the case has been updated with the following: -investigation results updated.-imdrf codes (b, c, d and g) were updated.-narrative updated accordingly.Final manufacturer's comment: (b)(6) 2021: the suspected device (novopen echo) has not been returned to novo nordisk a/s for the investigation.The batch trend analysis and reference sample examination revealed nothing abnormal.No abnormalities relating to the observed problem were found.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.Patient's underlying medical condition of type 1 diabetes mellitus is a risk factor for development of diabetic ketoacidosis.Reported events are listed.This single case report is not considered to change the current knowledge of the safety profile of novolog penfill.H3 continued: evaluation summary name: novopen echo - batch kvg0m24-3.The product was not returned for examination.The batch documentation was reviewed.No abnormalities relating to the observed problem were found.The batch documentation has been reviewed and found to be normal.

• Brand Name: NOVOPEN ECHO
• Common Device Name: INSULIN DELIVERY DEVICE
• Manufacturer (Section D): NOVO NORDISK A/S, MEDICAL SYSTEMS; hilleroed, ; DA
• MDR Report Key: 11507338
• Report Number: 9681821-2021-00013
• Device Sequence Number: 11474075
• Product Code: FMF
• UDI-Device Identifier: 00301691854591
• UDI-Public: 00301691854591
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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): 03/11/2021

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: 05/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 185459
• Device Lot Number: KVG0M24-3
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/11/2021
• Supplement Date Received by Manufacturer: 05/20/2021
• Initial Report FDA Received Date: 03/17/2021
• Supplement Report FDA Received Date: 06/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other