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

Model Number N/A

Device Problem Failure to Deliver (2338)

Patient Problems Hyperglycemia (1905); Coma (2417)

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas) hyperglycemic coma during using novopen4 [diabetic hyperglycaemic coma] novopen4 had a problem and was not injecting the dose [device failure].Case description: study id: 1777-outbound patient calls.Study description: the objective of the programme is to perform outbound calls to the patients who have received samples of novo nordisk egypt products.This is to confirm that they have received the sample, and verify if they have any problems with regard to the product received, or any problem with regard to diabetes.The patient's height, weight and body mass index were not reported.This serious solicited report from egypt was reported by a consumer as "hyperglycemic coma during using novopen4(coma hyperglycemic)" with an unspecified onset date , "novopen4 had a problem and was not injecting the dose(device failure)" with an unspecified onset date and concerned a female patient (age was not reported) who was treated with novopen 4 (insulin delivery device) from unknown start date for "device therapy", , insulin (insulin) , a non-novo nordisk suspect product insulin (insulin) (dose, frequency & route used - unk, unknown) from unknown start date for "drug use for unknown indication".Current condition: diabetes mellitus (type and duration not reported).On an unknown date the patient suffered from hyperglycemic coma during the use of novopen4.It was reported that, the patient had a problem in novopen4 which was not injecting the dose, so patient was not taking the insulin dose which lead to hyperglycemia.Batch number of novopen 4 and insulin was not available.Action taken to novopen 4 was not reported.Action taken to insulin was not reported.The outcome for the event "hyperglycemic coma during using novopen4(coma hyperglycemic)" was not reported.The outcome for the event "novopen4 had a problem and was not injecting the dose(device failure)" was not reported.Reporter's causality (novopen 4): hyperglycemic coma during using novopen4(coma hyperglycemic): unknown.Novopen4 had a problem and was not injecting the dose(device failure): unknown.Company's causality (novopen 4): hyperglycemic coma during using novopen4(coma hyperglycemic): possible.Novopen4 had a problem and was not injecting the dose(device failure): possible.Reporter's causality (insulin): hyperglycemic coma during using novopen4(coma hyperglycemic): unknown.Novopen4 had a problem and was not injecting the dose(device failure): unknown.Company's causality (insulin): hyperglycemic coma during using novopen4(coma hyperglycemic): possible.Novopen4 had a problem and was not injecting the dose(device failure): possible.If the sample is received, the device will be investigated to evaluate it works according to the set specifications and intended use.No further information available.

Event Description

Case description: this serious solicited report from egypt was reported by a consumer as "hyperglycemic coma during using novopen4(coma hyperglycemic)" with an unspecified onset date , "novopen4 had a problem and was not injecting the dose(device failure)" with an unspecified onset date and concerned a female patient (age was not reported) who was treated with novopen 4 (insulin delivery device) from unknown start date for "device therapy", and suspect product insulin (insulin) from unknown start date for "drug use for unknown indication".Investigation results: name: novopen® 4, batch : unknown, no investigation was possible, because neither sample nor batch number was available.Name : insulin.Batch : unknown.No investigation was possible, because neither sample nor batch number was available.Since last submission, the following has been updated, -investigation result updated.-annex b, c & d added.-manufacturer's comment added.-narrative updated accordingly.Final manufacturer's comment: 17-nov-2020: the suspected device (novopen 4, batch number unknown) has not been returned to novo nordisk for evaluation.Batch number of device is not available, no batch trend analysis performed.Relevant information on product handling, needle usage and leaving needle attached to device between injections, product training are unavailable.With limited information regarding the handling of suspected device, it is not possible to identify a clear root-cause of the experienced adverse event.H3 continued: evaluation summary: investigation results: name : novopen® 4, batch : 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: 10775371
• MDR Text Key: 217146640
• Report Number: 9681821-2020-00050
• 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: 10/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2020
• 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: 11/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization