MAUDE Adverse Event Report: NOVO NORDISK A/S NOVOPEN 6; INSULIN DELIVERY DEVICE

Model Number N/A

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas) novopen 6 blue no longer displays anything and the screen is black [device information output issue] hospital admission [hospitalisation].Case description: this serious spontaneous case from france was reported by a nurse as " novopen 6 blue no longer displays anything and the screen is black(device image display issue)" with an unspecified onset date, "hospital admission (hospitalisation)" with an unspecified onset date, and concerned a 15 years old male patient who was treated with novopen 6 (insulin delivery device) from unknown start date for "device therapy", patient height, weight, and body mass index were not reported.Current condition: diabetes(type and duration not reported).On an unknown date, patient novopen 6 blue no longer displays anything and the screen was black.He only had it for a month.The patient was admitted to the hospital (details of hospitalization unknown) without providing any indication as to the relationship with his diabetic condition.Batch number of novopen 6: nvgab17.Action taken to novopen 6 was reported as unknown.The outcome for the event " novopen 6 blue no longer displays anything and the screen is black(device image display issue)" was not reported.The outcome for the event "hospital admission(hospitalisation)" was unknown.No further information available "this report is for a foreign device that is assessed as "similar" to us marketed novopen echo".Preliminary manufacturer's comment: 23-nov-23: the suspected device novopen 6 has not been returned to novo nordisk for evaluation.No conclusion is reached.

Event Description

Case description: investigation results: novopen 6 bleu, batch number: nvgab17.The number of complaints on the batch was evaluated and, when applicable, relevant actions were taken.The product was not returned for examination.Since last submission the following were updated: -investigation results were updates.-b,c,d,g codes were updated.-malfunction updated.-narrative was updated accordingly.References included: reference type: (b)(4), company number.Reference id#: fr-novoprod-(b)(4).Reference type: mw 3500a mfr.Rpt.#.Reference id#: 9681821-2023-00164.Reference notes: medwatch 3500a mfr.Report number.Final manufacturer's comment: 23-jan-2024: the suspected device novopen 6 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 6.With available limited information, patient could be hospitalized for underlying diabetes management.H3 continued: evaluation summary novopen 6 bleu, batch number: nvgab17.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 6
• Type of Device: INSULIN DELIVERY DEVICE
• Manufacturer (Section D): NOVO NORDISK A/S; bagsvaerd,, ; 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: 18291379
• MDR Text Key: 330049002
• Report Number: 9681821-2023-00164
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K123766
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: N/A
• Device Lot Number: NVGAB17
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2023
• 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; Hospitalization
• Patient Age: 15 YR
• Patient Sex: Male