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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Fall (1848); Bone Fracture(s) (1870); Hypoglycemia (1912); Diabetic Ketoacidosis (2364); Convulsion/Seizure (4406)

Event Date 09/05/2021

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas).Diabetic ketoacidosis [diabetic ketoacidosis] hypoglycaemia [hypoglycaemia] fall [fall] fracture [fracture] seizure [seizure].Case description: this serious spontaneous regulatory authority case received via medsafe, from new zealnad was reported by a consumer as "diabetic ketoacidosis(diabetic ketoacidosis)" beginning on (b)(6) 2021, "fall(fall)" beginning on (b)(6)2021, "fracture(fracture)" beginning on (b)(6) 2021, "hypoglycaemia(hypoglycaemia)" beginning on 05-sep-2021, "seizure(seizure)" beginning on 05-sep-2021, and concerned a 57 years old male patient who was treated with novopen (insulin delivery device) from unknown start date for "device therapy", , a non-novo nordisk suspect product jardiance (empagliflozin) from (b)(6) 2021 to (b)(6) 2021 for "product used for unknown indication", the patient's height, weight and body mass index were not reported.Dosage regimens: novopen: jardiance: (b)(6) 2021; medical history was not provided.Concomitant products included - metformin, warfarin.On (b)(6) 2021, the patient experienced diabetic ketoacidosis, fall, fracture, hypoglycaemia and seizure.Batch numbers: novopen: not available.Jardiance: action taken to novopen was not reported.The outcome for the event "diabetic ketoacidosis(diabetic ketoacidosis)" was recovered.The outcome for the event "fall(fall)" was recovered.The outcome for the event "fracture(fracture)" was recovered.The outcome for the event "hypoglycaemia(hypoglycaemia)" was recovered.The outcome for the event "seizure(seizure)" was recovered.No further information is available.//uslz references included: reference type: e2b authority number reference id#: (b)(4).Reference notes: medsafe.The suspected device novopen (details unknown) has not been returned to novo nordisk for evaluation.The specific name of the novopen device, insulin used with novopen device, device handling and storing are unavailable.No conclusion reached.Patient might have developed hypoglycaemia, leading to seizures, and then had fall and fracture.Hypoglycaemia could be related to oral hypoglycaemic agent and insulin.

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas) case description: investigation results: suspect product name : novopen; batch number : unknown no investigation was possible, because neither sample nor batch number was available.Since last submission the case has been updated with the following: investigation results added.Annex b, c, d and g codes updated relevant fields updated in eu/ca tab narrative updated accordingly.Final manufacturer's comment: (b)(6)2024: the suspected device novopen (details unknown) has not been returned to novo nordisk for evaluation.The specific name of the novopen device, insulin used with novopen device, device handling and storing are unavailable.Batch number of devices is not available despite repeated efforts find the same.Batch trend analysis or reference sample analysis was not performed.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.Hypoglycaemia could be related to oral hypoglycaemic agent and insulin.H3 continued: evaluation summary suspect product name : novopen; batch number : unknown no investigation was possible, because neither sample nor batch number was available.

• Brand Name: NOVOPEN
• Type of Device: INSULIN DELIVERY DEVICE
• Manufacturer (Section D): NOVO NORDISK A/S; bagsvaerd,, ; DA
• Manufacturer (Section G): NOVO NORDISK A/S, MEDICAL SYSTEMS; brennum park; hilleroed,, 3400 ; DA 3400
• Manufacturer Contact: p.o. box 846; plainsboro, NJ 08536 ; 8007276500
• MDR Report Key: 18449846
• MDR Text Key: 332168216
• Report Number: 9681821-2024-00006
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• Reporter Country Code: NZ
• PMA/PMN Number: K861686
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: N/A
• Device Catalogue Number: 185230
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: METFORMIN (METFORMIN).; WARFARIN (WARFARIN).
• Patient Outcome(s): Life Threatening
• Patient Age: 57 YR
• Patient Sex: Male