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

Model Number N/A

Device Problem Failure to Fire (2610)

Patient Problems Hypoglycemia (1912); Missed Dose (2561)

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas) blood glucose 63 mg/dl [blood glucose decreased].Piston some times didn't touch the back of the penfill [device malfunction].Wasn't sure if he took his full dose [incorrect dose administered by device].Case description: study id: (b)(4)-novocare programme study description: trial title: 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 weight: (b)(6) kg.Patient's height and body mass index (bmi) not reported.This serious solicited report from (b)(6) was reported by a consumer as "blood glucose 63 mg/dl(blood glucose decreased)" with an unspecified onset date , "piston sometimes didn't touch the back of the penfill(device component malfunction)" with an unspecified onset date , "wasn't sure if he took his full dose(partial dose delivery by device)" with an unspecified onset date and concerned a (b)(6)-year-old male patient who was treated with novopen 4 (insulin delivery device) from unknown start date for "diabetes mellitus", mixtard 30 hm penfill (insulin human) from (b)(6) 2019 and ongoing for "diabetes mellitus" (dose and frequency 30iu am and 20 iu pm s/c flat skin).Current condition included diabetes mellitus (type and duration not reported).Concomitant medications included - insulin and glibenese [glipizide](glipizide).On an unknown date the patient took regular mixtard dose with novopen 4, but after taking it out and trying it in the air it was stiff and piston didn't touch the back of the penfill.The patient was not sure if full dose was taken or not so took a glibenese tab to compensate the lost dose.Later patient was hospitalized with blood glucose values of 63 mg/dl and patient took sugar source as a treatment.Batch numbers for novopen 4, mixtard 30 hm penfill were requested but not available.Action taken to novopen 4 was not reported.Patient replaced novopen4 with another new novopen4.Action taken to mixtard 30 hm penfill was reported as no change.The outcome for the event "blood glucose 63 mg/dl(blood glucose decreased)" was unknown.The outcome for the event "piston some times didn't touch the back of the penfill(device component malfunction)" was not reported.The outcome for the event "wasn't sure if he took his full dose(partial dose delivery by device)" was not reported.Reporter's causality (novopen 4) - blood glucose 63 mg/dl(blood glucose decreased) : probable piston some times didn't touch the back of the penfill(device component malfunction) : unknown wasn't sure if he took his full dose(partial dose delivery by device) : unknown.Company's causality (novopen 4) - blood glucose 63 mg/dl(blood glucose decreased) : possible piston some times didn't touch the back of the penfill(device component malfunction) : possible wasn't sure if he took his full dose(partial dose delivery by device) : possible.Reporter's causality (mixtard 30 hm penfill) - blood glucose 63 mg/dl(blood glucose decreased) : unlikely piston some times didn't touch the back of the penfill(device component malfunction) : unknown wasn't sure if he took his full dose(partial dose delivery by device) : unknown.Company's causality (mixtard 30 hm penfill) - blood glucose 63 mg/dl(blood glucose decreased) : possible piston some times didn't touch the back of the penfill(device component malfunction) : possible wasn't sure if he took his full dose(partial dose delivery by device) : possible.References included: reference type: e2b company number.Reference id#: (b)(4).Manufacturer comment: patient experienced hypoglycaemia while using a pen with malfunction.Moreover the patient took glipizide (oral anti-diabetic medication) to compensate for earlier dose which was believed to be insufficient.Therefore, it is most likely that additional oral hypoglycemic medication and device malfunction has contributed to hypoglycaemic event.Reporter comment: duration of use of the product was about 2 months.

Event Description

Case description: investigation results.Name: novopen 4; batch number: unknown; no investigation was possible, because neither sample nor batch number was available.Name: mixtard 30 penfill 3 ml 100iu/ml; 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 updated.Manufacturer's comment updated.Narrative updated accordingly.Manufacturer comment: 20-jan-2020: as the device (novopen 4) has not been returned to novo nordisk a/s for investigation and only very limited information regarding the handling of suspected device is available, it is not possible to identify a clear root-cause of the experienced adverse event and thus find similar incidents to the one reported in argus case (b)(4).Patient experienced hypoglycaemia while using a pen with malfunction.Moreover the patient took glipizide (oral anti-diabetic medication) to compensate for ealier dose which was believed to be insufficient.Therefore, it is most likely that additional oral hypoglycamic medication and device malfunction has contributed to hypoglycaemic event.H3 continued: evaluation summary; name : novopen 4; batch number: unknown; no investigation was possible, because neither sample nor batch number was available.

• Brand Name: NOVOPEN 4
• Type of Device: INSULIN DELIVERY DEVICE
• Manufacturer (Section D): NOVO NORDISK A/S, MEDICAL SYSTEMS; hilleroed, ; DA
• MDR Report Key: 9329949
• MDR Text Key: 185723386
• Report Number: 9681821-2019-00076
• 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
• Report Date: 10/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2019
• 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 Catalogue Number: 185490
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GLIBENESE [GLIPIZIDE] (GLIPIZIDE).; INSULIN (INSULIN).
• Patient Outcome(s): Hospitalization
• Patient Age: 66 YR
• Patient Weight: 92