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

Model Number N/A

Device Problem Difficult to Advance (2920)

Patient Problems Pain (1994); Reaction, Injection Site (2442)

Event Date 05/10/2020

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas) push button hard to depress [device malfunction] injection site pain [injection site pain] case description: this serious spontaneous regulatory authority case received via nmpa (national medical products administration), chn from (b)(6).Was reported by a health care professional as "push button hard to depress(device component malfunction)" beginning on (b)(6) 2020, "injection site pain(injection site pain)" beginning on (b)(6) 2020, and concerned a (b)(6)-year-old female patient who was treated with novopen 4 (insulin delivery device) from (b)(6) 2020 for "diabetes mellitus".The patient's height, weight and body mass index were not reported.Dosage regimens: novopen 4: (b)(6) 2020 to not reported.Current condition: diabetes mellitus (type and duration not reported).Historical condition: hyperglycemia.It was reported that the patient was given long-term insulin injection due to years of history of hyperglycemia.On (b)(6) 2020, the patient used novopen 4 to inject insulin and found the push button hard to depress, the same situation happened when the patient asked her family for help.The patient experienced injection site pain also.Novopen was changed with new pen.Batch numbers: novopen 4: unknown.Action taken to novopen 4 was reported as product discontinued due to adverse event (ae).The outcome for the event "push button hard to depress(device component malfunction)" was not reported.The outcome for the event "injection site pain(injection site pain)" was not reported.No further information available.References included: reference type: e2b report duplicate.Reference id#: (b)(6).Reference notes: nmpa (national medical products administration), chn.

Event Description

Case description: investigation results: name: novopen® 4; batch: unknown.No investigation was possible, because neither sample nor batch number was available.Since last submission, the following has been updated in the case: investigation results updated; manufacturer comment updated; narrative updated accordingly.Manufacturer comment: (b)(6) 2020: the suspected device (novopen 4) has not been returned to novo nordisk for evaluation.With limited information regarding the handling of suspected device, it is not possible to identify a clear root-cause of the experienced adverse event and thus find similar incidents.Elderly age of the patient (73 years) is a risk factor for improper use leading to pain at the injection site.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: 10282807
• MDR Text Key: 203281845
• Report Number: 9681821-2020-00033
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 06/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2020
• 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: 07/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 73 YR