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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hypoglycemia (1912)

Event Date 06/04/2022

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas) hypoglycemia [hypoglycaemia].Case description: study id: (b)(6).Study description: this is a multi-centre, prospective, single-arm, non-interventional clinical investigation, studying the glycaemic control in patients with type 1 diabetes when introducing a novopen 6 for treatment with tresiba (insulin degludec) and fiasp (fast-acting insulin aspart) in a real-world setting.Patient's height: 189 cm.Patient's weight: 90 kg.Patient's bmi: 25.19526330.This serious solicited report from (b)(6) was reported by a health care professional as "hypoglycemia(hypoglycemia)" beginning on (b)(6) 2022 and concerned a (b)(6) male patient who was treated with novopen 6 (insulin delivery device) on (b)(6) 2021, for "type1 diabetes mellitus".Current condition: type 1 diabetes mellitus ((b)(6) 1978), diabetic retinopathy ((b)(6) 1996), addison disease ((b)(6) 2012), hypertonia (2005), asthma bronchiale ((b)(6) 2010), sleep apnoe, ((b)(6) 2011) and hyperlipidemia ((b)(6) 2018).On (b)(6) 2022, patient experienced hypoglycemia with blood glucose values of 1.8 mmol/l and the patient required hospitalization for the same.The patient was discharged on the same date.Batch numbers of novopen 6 not reported.On (b)(6) 2022 the outcome for the event "hypoglycemia(hypoglycemia)" was recovered.Reporter's causality (novopen 6) - hypoglycemia(hypoglycemia) : probable.Company's causality (novopen 6) - hypoglycemia(hypoglycemia) : possible.This report is for a foreign device that is assessed as "similar" to us marketed novopen echo.Reporter comment: addison's disease reported as alternate aetiology for the event.

Event Description

Case description: reporter's causality (novopen 6) - hypoglycemia(hypoglycemia) : unlikely.Company's causality (novopen 6) - hypoglycemia(hypoglycemia) : unlikely.Since last submission the following information has been updated; -reporter causality of the event updated from probable/possible to unlikely/possible.-narrative updated accordingly.On 08-aug-2022, the causality assessment of the event 'hypoglycemia' was downgraded from 'probable/possible' to unlikely/possible' from the investigator.The case is considered as non-reportable as there is no casual relationship and no technical compliant reported with the novopen 6.The suspected device novopen 6 has not been returned to novo nordisk for evaluation.The case will not qualify as reportable device incident.

Event Description

Case description: investigation result: novopen 6.No investigation was possible, because neither sample nor batch number was available.Since last submission the following information has been updated; investigation result updated.Annex b, c, d and g codes updated.Malfunction field updated from 'yes" to "no".Narrative updated accordingly.The correct ird of the case was 04-aug-2022, however during triage step it was captured 08-aug-2022 by an error.This was identified during reconciliation.Hence an amr has been filed.Company comment: 24-aug-2022:the causality from the investigator updated from probable to unlikely related to novopen 6.The relevant information on technical complaint with novopen 6 is unavailable.The suspected device novopen 6 has not been returned to novo nordisk for evaluation.The case will not qualify as reportable device incident.H3 continued: evaluation summary.Novopen 6.No investigation was possible, because neither sample nor batch number was available.

• 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: 14874912
• MDR Text Key: 295049787
• Report Number: 9681821-2022-00055
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K123766
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2022
• 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): Hospitalization
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 90 KG