MAUDE Adverse Event Report: NOVO NORDISK A/S NOVOPEN; INSULIN DELIVERY DEVICE

Model Number N/A

Device Problem Mechanical Problem (1384)

Patient Problem Loss of consciousness (2418)

Event Type  Injury  

Event Description

Unconscious [loss of consciousness].Device failure [device failure].Case description: this serious spontaneous case from (b)(6) was reported by a consumer as "unconscious (unconscious)" with an unspecified onset date, "device failure (device failure)" with an unspecified onset date, and concerned a female patient who was treated with novopen (insulin delivery device) from unknown start date for "device therapy", , novorapid penfill (insulin aspart) from unknown start date for "product used for unknown indication" (dose and frequency unknown), patient's height, weight and bmi was not reported.Dosage regimens were not reported.On an unknown date, novorapid penfill device (novopen), failed and the patent was unconscious.Batch numbers was requested.Action taken to novopen was reported as unknown.Action taken to novorapid penfill was not reported.The outcome for the event "unconscious (unconscious)" was unknown.The outcome for the event "device failure (device failure)" was not reported.Company comment: loss of consciousness is assessed as unlisted according to the novo nordisk current ccds on novorapid penfill.Information on final diagnosis, clinical and laboratory investigation results including blood glucose values at the time of event, treatment received and concomitant medication details are not available for complete medical assessment of the case.This single case report is not considered to change the current knowledge of the safety profile of novorapid penfill.

Event Description

Case description: investigation result: name:novopen -batch unknown.No investigation was possible, because neither sample nor batch.Number was available.Name:novorapid penfill -batch unknown.No investigation was possible, because neither sample nor batch number was available.Since last submission the case has been updated with the following information: investigation results updated.Manufacturer's comment updated.Narrative updated.Manufacturer's comment: (b)(6) 2020: as the device (novopen) 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).Loss of consciousness is assessed as unlisted according to the novo nordisk current ccds on novorapid penfill.Information on final diagnosis, clinical and laboratory investigation results including blood glucose values at the time of event, treatment received and concomitant medication details are not available for complete medical assessment of the case.This single case report is not considered to change the current knowledge of the safety profile of novorapid penfill.H3 continued: evaluation summary name:novopen batch unknown no investigation was possible, because neither sample nor batch number was available.

• Brand Name: NOVOPEN
• Type of Device: INSULIN DELIVERY DEVICE
• Manufacturer (Section D): NOVO NORDISK A/S; bagsvaerd, ; DA
• MDR Report Key: 9604931
• MDR Text Key: 189634576
• Report Number: 9681821-2020-00003
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• PMA/PMN Number: K861686
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 12/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: N/A
• Device Catalogue Number: 185230
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/22/2019
• Initial Date FDA Received: 01/19/2020
• Supplement Dates Manufacturer Received: 01/29/2020
• Supplement Dates FDA Received: 02/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other