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

Model Number N/A

Device Problems Restricted Flow rate (1248); Mechanical Jam (2983)

Patient Problems Abscess (1690); Hyperglycemia (1905)

Event Type  Injury  

Event Description

Leg abscess lead to surgical operation [abscess limb].Blood glucose elevated [blood glucose increased].Novopen 4 was not working properly(the piston rod was stuck inside the mechanical part even after adjusting the dose counter to 60 u) and didn't take the accurate dose [device malfunction], [incorrect dose administered by device].Case description: this serious spontaneous case from (b)(6) was reported by a consumer as "leg abscess lead to surgical operation" with an unspecified onset date, "blood glucose elevated" with an unspecified onset date, "novopen 4 was not working properly(the piston rod was stuck inside the mechanical part even after adjusting the dose counter to 60 u) and didn't take the accurate dose" with an unspecified onset date, "novopen 4 was not working properly and didn't take the accurate dose" with an unspecified onset date, and concerned a female patient (age not reported) who was treated with novopen 4 (insulin delivery device) from unknown start date due to "diabetes mellitus", insulin (insulin) from unknown start date due to "diabetes mellitus".Patient's height, weight and bmi: not reported.Medical history included diabetes mellitus (type and duration unknown).On an unknown date, novopen 4 was not working properly as the patient did not feel the insulin during injection.During pen training, the piston rod was stuck inside the mechanical part even after adjusting the dose counter to 60 u and press on the dose button twice.On an unknown date, the patient developed abscess in her leg after elevation of her blood glucose level.Patient was hospitalized and underwent a surgical operation on (b)(6) 2018.Patient noticed high glucose level in the second day of hospitalization on (b)(6) "2019".Batch number of novopen 4 was available 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 "leg abscess lead to surgical operation" was unknown.The outcome for the event "blood glucose elevated" was not reported.The outcome for the event "novopen 4 was not working properly (the piston rod was stuck inside the mechanical part even after adjusting the dose counter to 60 u) and didn't take the accurate dose" was not reported.The outcome for the event "novopen 4 was not working properly and didn't take the accurate dose" was not reported.No further information available.Reporter comment: reporter said that tc is associated to hyperglycemia and causing abcess as she didn't take the accurate dose.

Event Description

Case description: investigation result: name: novopen® 4, batch number: fvg7971-1.The product was not returned for examination.The complaint has been registered in the novo nordisk complaint handling system.Since last submission, the case has been updated with the following: investigation result updated.Manufacturer's comment updated.Narrative updated.Manufacturer comment: on 25-feb-2019: 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).Evaluation summary: name: novopen® 4, batch number: fvg7971-1.The product was not returned for examination.The complaint has been registered in the novo nordisk complaint handling system.

• Brand Name: NOVOPEN 4
• Type of Device: INSULIN DELIVERY DEVICE
• Manufacturer (Section D): NOVO NORDISK A/S, MEDICAL SYSTEMS; hilleroed, ; DA
• MDR Report Key: 8292689
• MDR Text Key: 134597382
• Report Number: 9681821-2019-00008
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: 20-986
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 12/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 185490
• Device Lot Number: FVG7971-1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention