MAUDE Adverse Event Report: NOVO NORDISK A/S, MEDICAL SYSTEMS NOVOPEN 4; INSULIN DELIVERY DEVICE

Model Number N/A

Device Problem No Device Output (1435)

Patient Problem Coma (2417)

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas) novopen 4 has not released insulin [device failure], coma [coma].Case description: study id: (b)(6) study description: main objective of the programme is to help patients to understand their diabetes and maintain normal life through qualified educators who offer simple and practical information directly to the patients and also, train patients on how to use their insulin devices and needles etc.Patient's height, weight and body mass index (bmi) were not reported.This serious solicited report from (b)(6) was reported by a consumer as "novopen 4 has not released insulin(device failure)" with an unspecified onset date , "coma(coma)" with an unspecified onset date and concerned a (b)(6) years old female patient who was treated with novopen 4 (insulin delivery device) from unknown start date for "diabetes mellitus", insulatard penfill (insulin human) from unknown start date and ongoing for "diabetes mellitus" (dose and frequency unk (4 years ago till now)), actrapid penfill (insulin human) from unknown start date and ongoing for "diabetes mellitus" (dose and frequency 50 iu, qd (4 years ago till now)).Current condition: diabetes mellitus (type and duration not reported).It was reported that the patient was hospitalized from (b)(6) 2020 due to pen not releasing insulin and going into coma.The suspected novopen 4 has been changed to another pen (unspecified) after replacing the used one during which the patient developed coma due to device failure.Batch numbers: novopen 4: dvg2032-1.Insulatard penfill: requested but unknown.Actrapid penfill: requested but unknown.Action taken to novopen 4 was product discontinued to adverse event (ae).Action taken to insulatard penfill was no change.Action taken to actrapid penfill was no change.The outcome for the event "novopen 4 has not released insulin(device failure)" was not reported.The outcome for the event "coma(coma)" was not reported.Reporter's causality (novopen 4) - novopen 4 has not released insulin(device failure) : probable.Coma(coma) : probable.Company's causality (novopen 4) - novopen 4 has not released insulin(device failure) : possible.Coma(coma) : unlikely.Reporter's causality (insulatard penfill) - novopen 4 has not released insulin(device failure) : unlikely.Coma(coma) : unlikely.Company's causality (insulatard penfill) - novopen 4 has not released insulin(device failure) : possible.Coma(coma) : unlikely.Reporter's causality (actrapid penfill) - novopen 4 has not released insulin(device failure) : unlikely.Coma(coma) : unlikely.Company's causality (actrapid penfill) - novopen 4 has not released insulin(device failure) : possible.Coma(coma) : unlikely.No further information available.References included: reference type: e2b company number.Reference id#: (b)(4).Reference notes: manufacturer preliminary comment: relevant information on user of the device, product handling training and device storage are unavailable.The suspected device has not been returned to novo nordisk for evaluation.No conclusion has been reached on the reported event of coma.Considering the age of the patient, underlying diabetes mellitus, no change with insulatard and actrapid, coma could be attributed to complications of diabetes mellitus.

Event Description

Case description: investigation results: name: novopen® 4, batch: dvg2032-1.The product was not returned for examination.No investigation was possible, because neither sample nor batch number was available.Name: insulatard® penfill® 3 ml 100iu/ml, batch: unknown.No investigation was possible, because neither sample nor batch number was available.Name: actrapid® penfill® 3 ml 100iu/ml batch: unknown no investigation was possible, because neither sample nor batch number was available.Since last submission, the following information has been updated: - investigation results updated - manufacturer's comment updated.- narrative updated accordingly final manufacturer comment: the suspected device (novopen 4) has not been returned to novo nordisk for evaluation.The reference sample was found to be normal.With limited information regarding the handling of suspected device, it is not possible to identify a clear root-cause of the experienced adverse event.Considering the age of the patient (13 years), the reported coma could be the complication of diabetic ketoacidosis which is common in type 1 diabetes mellitus.H3 continued: evaluation summary investigation results: name: novopen® 4 batch: dvg2032-1 the product was not returned for examination.No investigation was possible, because neither sample nor batch number was available.

Event Description

Case description: on (b)(6) 2020, an amendment was performed.Since last submission, the following information has been amended.-final manufacturer's comment was updated in the narrative.Final manufacturer comment: the suspected device (novopen 4) has not been returned to novo nordisk for evaluation.The reference sample was found to be normal.With limited information regarding the handling of suspected device, it is not possible to identify a clear root-cause of the experienced adverse event.Considering the age of the patient (13 years), the reported coma could be the complication of diabetic ketoacidosis which is common in type 1 diabetes mellitus.Company comment coma is assessed as unlisted according to the novo nordisk current ccds in insulatard penfill and actrapid penfill.Relevant information on user of the device, product handling training and device storage are unavailable.The suspected device has not been returned to novo nordisk for evaluation.No conclusion has been reached on the reported event of coma.Considering the age of the patient, underlying diabetes mellitus, no change with insulatard and actrapid, coma could be attributed to complications of diabetes mellitus.This single case report is not considered to change the current knowledge of the safety profile of insulatard penfill and actrapid penfill.

• Brand Name: NOVOPEN 4
• Type of Device: INSULIN DELIVERY DEVICE
• Manufacturer (Section D): NOVO NORDISK A/S, MEDICAL SYSTEMS; hilleroed, ; DA
• MDR Report Key: 10257192
• MDR Text Key: 207926541
• Report Number: 9681821-2020-00032
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• PMA/PMN Number: 20-986
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,study
• Type of Report: Initial,Followup,Followup
• Report Date: 06/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/01/2019
• Device Model Number: N/A
• Device Catalogue Number: 185490
• Device Lot Number: DVG2032-1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 13 YR