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

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Fall (1848); Hypoglycemia (1912); Injury (2348); Reaction, Injection Site (2442)

Event Date 05/11/2019

Event Type  Injury  

Event Description

Hypoglycemia, unconscious and fell down [hypoglycaemic unconsciousness].Pen doesn't work properly [device malfunction].Unsure of the units delivered by novopen 4 so injected additional units [extra dose administered].Hardly pressed of novopen 4 [wrong technique in product usage process].Blood glucose level elevated 500mg/dl [blood glucose increased].Needle hurt him [injection site injury].Fell down and got injured [injury].Used dialling clicks to estimate the insulin dose [wrong technique in product usage process].Pain at injection site [injection site pain].Case description: study id: (b)(6).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 height, weight and body mass index (bmi) not reported.This serious solicited report from egypt was reported by a consumer as "hypoglycemia, unconscious and fell down" beginning on 11-may-2019, "pen doesn't work properly" beginning on 11-may-2019, "unsure of the units delivered by novopen 4 so injected additional units" beginning on 11-may-2019, "hardly pressed of novopen 4" with an unspecified onset date, "blood glucose level elevated 500mg/dl" with an unspecified onset date, "needle hurt him" with an unspecified onset date, "fell down and got injured" beginning on 11-may-2019, "used dialling clicks to estimate the insulin dose" with an unspecified onset date, "pain at injection site" beginning on 11-may-2019 and concerned a male patient (age not reported) who was treated with mixtard 30 penfill hm(ge) 3.0 ml (insulin human) from unknown start date due to "diabetes mellitus" (dose and frequency regimen #1 50-65 iu(started 10 years ago), regimen #2 60 iu), novopen 4 (insulin delivery device) from unknown start date due to "diabetes mellitus" and novofine 32g 6 mm (needle) from unknown start date due to "diabetes mellitus".Medical history included diabetes mellitus (since 20 years and type not reported).Concomitant medications included - ganaton(itopride hydrochloride), milga(benfotiamine, cyanocobalamin, pyridoxine hydrochloride), zinc(zinc), doxium(calcium dobesilate).On 11-may-2019, the patient complained that the pen was not working properly.So, the patient adjusted the dose counter on 60 units and injected himself.The patient became unsure of the number of units delivered and took additional units.It was reported that the patient didn't measure blood glucose before injecting the additional units.It was reported that the patient used the dialing clicks to estimate the dose of the insulin.On 11-may-2019, half an hour after taking the dose patient developed hypoglycemia.It was reported that patient was sweaty and experienced dizziness.The patient became unconscious, then fell down and got injured.The patient got hospitalized for the events.It was also reported that on an unknown date patient hardly pressed novopen 4 which lead to pain at injection site and novofine 32g 6 mm needle hurt him, patient was afraid to take his dose because of which patient's blood glucose level elevated to 500mg/dl.Batch number of novopen 4 was available.Action taken to mixtard 30 penfill hm(ge) 3.0 ml was not reported.Action taken to novopen 4 (insulin delivery device) was not reported.Action taken to novofine 32g 6 mm was not reported.The outcome for the event "hypoglycemia, unconscious and fell down" was recovered.The outcome for the event "pen doesn't work properly" was not reported.The outcome for the event "unsure of the units delivered by novopen 4 so injected additional units" was not reported.The outcome for the event "hardly pressed of novopen 4" was not reported.The outcome for the event "blood glucose level elevated 500mg/dl" was not reported.The outcome for the event "needle hurt him" was not reported.The outcome for the event "fell down and got injured" was recovered.The outcome for the event "used dialling clicks to estimate the insulin dose" was not reported.The outcome for the event "pain at injection site" was not reported.Reporter's causality ( mixtard 30 penfill hm(ge) 3.0 ml) - hypoglycemia, unconscious and fell down: unknown.Pen doesn't work properly: unknown.Unsure of the units delivered by novopen 4 so injected additional units: unknown.Hardly pressed of novopen 4: unknown.Blood glucose level elevated 500mg/dl: unknown.Needle hurt him: unknown.Fell down and got injured: unknown.Used dialling clicks to estimate the insulin dose: unknown.Pain at injection site: unknown.Company's causality ( mixtard 30 penfill hm(ge) 3.0 ml) - hypoglycemia, unconscious and fell down: possible.Pen doesn't work properly: possible.Unsure of the units delivered by novopen 4 so injected additional units: possible.Hardly pressed of novopen 4: possible.Blood glucose level elevated 500mg/dl: unlikely.Needle hurt him: possible.Fell down and got injured: unlikely.Used dialling clicks to estimate the insulin dose: possible.Pain at injection site: possible.Reporter's causality (novopen 4) - hypoglycemia, unconscious and fell down: probable.Pen doesn't work properly: probable.Unsure of the units delivered by novopen 4 so injected additional units: probable.Hardly pressed of novopen 4: probable.Blood glucose level elevated 500mg/dl: probable.Needle hurt him: probable.Fell down and got injured: probable.Used dialling clicks to estimate the insulin dose: probable.Pain at injection site: probable.Company's causality (novopen 4) - hypoglycemia, unconscious and fell down: possible.Pen doesn't work properly: possible.Unsure of the units delivered by novopen 4 so injected additional units: possible.Hardly pressed of novopen 4: possible.Blood glucose level elevated 500mg/dl: possible.Needle hurt him: possible.Fell down and got injured: unlikely.Used dialling clicks to estimate the insulin dose: possible.Pain at injection site: possible.Reporter's causality (novofine 32g 6 mm) - hypoglycemia, unconscious and fell down: unknown.Pen doesn't work properly: unknown.Unsure of the units delivered by novopen 4 so injected additional units: unknown.Hardly pressed of novopen 4: unknown.Blood glucose level elevated 500mg/dl: unknown.Needle hurt him: unknown.Fell down and got injured: unknown.Used dialling clicks to estimate the insulin dose: unknown.Pain at injection site: unknown.Company's causality (novofine 32g 6 mm) - hypoglycemia, unconscious and fell down: possible.Pen doesn't work properly: possible.Unsure of the units delivered by novopen 4 so injected additional units: possible.Hardly pressed of novopen 4: possible.Blood glucose level elevated 500mg/dl: unlikely.Needle hurt him : possible.Fell down and got injured: unlikely.Used dialling clicks to estimate the insulin dose: possible.Pain at injection site: possible.Company comment: injury is assessed as an unlisted event; hypoglycemic unconsciousness, blood glucose increased are assessed as a listed event according to the novo nordisk current company core data sheet (ccds) on mixtard 30 penfill.Administration of higher dose of mixtard 30 penfill (60 units), thinking that device is not functioning properly, is the plausible cause for hypoglycaemia resulting in fall and injury.Investigation results of the sample and novopen 4 will be helpful for complete causality assessment.This single case report is not considered to change the current knowledge of the safety profile of mixtard 30 penfill.

Event Description

Case description: it was reported that the patient did not re-used the needle and also did not leave the needle attached to the pen in between injections.The patient felt more resistance than normal when attaching the needle.The patient did not recently changed from another needle type to the current novofine.Batch number of novofine 32g 6 mm was not reported.Since last submission the case has been updated with the following information: information regarding needle updated in the narrative.

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas) hypoglycemia, unconscious and fell down [hypoglycemic unconsciousness].Pen doesn't work properly [device malfunction].Unsure of the units delivered by novopen 4 so injected additional units [extra dose administered].Hardly pressed of novopen 4 [wrong injection technique].Blood glucose level elevated 500mg/dl [blood glucose increased].Needle hurt him [injection site injury].Used dialling clicks to estimate the insulin dose [wrong technique in ct usage process].Pain at injection site [injection site pain].Case description: batch number of novofine 32g 6 mm and mixtard 30 penfill was not reported.The outcome for the event "hypoglycemia, unconscious and fell down" was recovered.The outcome for the event "pen doesn't work properly" was not reported.The outcome for the event "unsure of the units delivered by novopen 4 so injected additional units" was not reported.The outcome for the event "hardly pressed of novopen 4" was not reported.The outcome for the event "blood glucose level elevated 500mg/dl" was not reported.The outcome for the event "needle hurt him" was not reported.The outcome for the event "used dialling clicks to estimate the insulin dose" was not reported.The outcome for the event "pain at injection site" was not reported.Reporter's causality ( mixtard 30 penfill hm(ge) 3.0 ml) - hypoglycemia, unconscious and fell down : unknown.Pen doesn't work properly : unknown.Unsure of the units delivered by novopen 4 so injected additional units : unknown.Hardly pressed of novopen 4 : unknown.Blood glucose level elevated 500mg/dl : unknown.Needle hurt him : unknown.Used dialling clicks to estimate the insulin dose : unknown.Pain at injection site : unknown.Company's causality ( mixtard 30 penfill hm(ge) 3.0 ml) - hypoglycemia, unconscious and fell down : possible.Pen doesn't work properly : possible.Unsure of the units delivered by novopen 4 so injected additional units : possible.Hardly pressed of novopen 4 : possible.Blood glucose level elevated 500mg/dl : unlikely.Needle hurt him : possible.Used dialling clicks to estimate the insulin dose : possible.Pain at injection site : possible.Reporter's causality ( novopen 4) - hypoglycemia, unconscious and fell down : probable.Pen doesn't work properly : probable.Unsure of the units delivered by novopen 4 so injected additional units : probable.Hardly pressed of novopen 4 : probable.Blood glucose level elevated 500mg/dl : probable.Needle hurt him : probable.Used dialling clicks to estimate the insulin dose : probable.Pain at injection site : probable.Company's causality ( novopen 4) - hypoglycemia, unconscious and fell down : possible.Pen doesn't work properly : possible.Unsure of the units delivered by novopen 4 so injected additional units : possible.Hardly pressed of novopen 4 : possible.Blood glucose level elevated 500mg/dl : possible.Needle hurt him : possible.Used dialling clicks to estimate the insulin dose : possible.Pain at injection site : possible.Reporter's causality ( novofine 32g 6 mm) - hypoglycemia, unconscious and fell down : unknown.Pen doesn't work properly : unknown.Unsure of the units delivered by novopen 4 so injected additional units : unknown.Hardly pressed of novopen 4 : unknown.Blood glucose level elevated 500mg/dl : unknown.Needle hurt him : unknown.Used dialling clicks to estimate the insulin dose : unknown.Pain at injection site : unknown.Company's causality ( novofine 32g 6 mm) - hypoglycemia, unconscious and fell down : possible.Pen doesn't work properly : possible.Unsure of the units delivered by novopen 4 so injected additional units : possible.Hardly pressed of novopen 4 : possible.Blood glucose level elevated 500mg/dl : unlikely.Needle hurt him : possible.Used dialling clicks to estimate the insulin dose : possible.Pain at injection site : possible.Investigation results: name: mixtard 30 penfil 3 ml 100iu/ml - batch number: unknown.No investigation was possible, because neither sample nor batch number was available.Name: novopen 4 - batch number: dug0863.The product was not returned for examination.The batch documentation has been reviewed.Nothing abnormal was found.Name: novofine 32g tip 6mm - 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: -investigational results received.-manufacturer's comment updated.-narrative updated.Company comment: injury is assessed as an unlisted event; hypoglycemic unconsciousness, blood glucose increased are assessed as a listed event according to the novo nordisk current company core data sheet (ccds) on mixtard 30 penfill.Administration of higher dose of mixtard 30 penfill (60 units), thinking that device is not functioning properly, is the plausible cause for hypoglycaemia resulting in fall and injury.Investigation results of the sample and novopen 4 will be helpful for complete causality assessment.This single case report is not considered to change the current knowledge of the safety profile of mixtard 30 penfill.On 30-aug-2019: as the device (novopen 4 and novofine 32g 6mm) 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).Continued: evaluation summary: novopen 4 - batch number: dug0863.The product was not returned for examination.The batch documentation has been reviewed.Nothing abnormal was found.

• Brand Name: NOVOPEN 4
• Type of Device: INSULIN DELIVERY DEVICE
• Manufacturer (Section D): NOVO NORDISK A/S, MEDICAL SYSTEMS; hilleroed, ; DA
• MDR Report Key: 8847475
• MDR Text Key: 152967542
• Report Number: 9681821-2019-00049
• 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: 06/27/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/30/2019
• Device Model Number: N/A
• Device Catalogue Number: 185490
• Device Lot Number: DUG0863
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DOXIUM (CALCIUM DOBESILATE).; GANATON (ITOPRIDE HYDROCHLORIDE).; MILGA.; ZINC (ZINC).
• Patient Outcome(s): Hospitalization; Other