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

Model Number N/A

Device Problems Failure to Fire (2610); Infusion or Flow Problem (2964)

Patient Problems Hyperglycemia (1905); Test Result (2695); No Code Available (3191)

Event Date 05/23/2018

Event Type  Injury  

Event Description

High blood sugars [blood glucose increased].Plunger would not depress and unable to inject as the pens failed [device failure].High glycosylated hemoglobin (a1c) [glycosylated haemoglobin increased].Case description: this serious spontaneous case from the united states was reported by a consumer as "high blood sugars" beginning on (b)(6) 2018, "plunger would not depress and unable to inject as the pens failed" beginning on (b)(6) 2018, "high glycosylated hemoglobin (a1c)" with an unspecified onset date, and concerned a (b)(6) -year-old male patient who was treated with novopen 4 (insulin delivery device) from unknown start date due to "type 2 diabetes mellitus" and novopen 4 (insulin delivery device) from unknown start date due to "type 2 diabetes mellitus".Patient height, weight or body mass index not reported.Medical history included type 2 diabetes mellitus (for over 20 years) and hypertension.Concomitant products included - novolin ge nph penfill (insulin human) suspension for injection, 100 iu/ml, novorapid penfill (insulin aspart) solution for injection, 100 u/ml.It was reported that on (b)(6) 2018 patient from (b)(6) had complaint about simultaneous product failures.The plungers on the two novopen 4 failed and would not depress and as a result, the patient experienced high blood sugars and high glycosylated hemoglobin (a1c).This occurred while patient was in (b)(6).It was considered serious diabetic crisis and blood sugar readings were significantly elevated.It was a medical emergency and patient went to see a doctor.On (b)(6) 2018, patient's blood glucose levels were 12.9 mmol/l, 6.1 mmol/l, 15.6mmol/l, 13.7mmol/l, 18.3mmol/l and 13mmol/l.On (b)(6) 2018, patient's blood glucose levels were 8.4mmol/l, 8.9mmol/l, 11.8mmol/l, 13.2mmol/l, 14.4mmol/l and 13.1mmol/l.On (b)(6) 2018, patient's blood glucose levels were 11.8mmol/l, 10.9mmol/l, 17.4mmol/l and 11.0mmol/l.Overall the average for 3 days was 12.7mmol/l.On an unknown date, patient glycosylated hemoglobin (a1c) values was 9%.It was reported that patient bought novolog disposable pen, which is equivalent to novorapid insulin and used it for 2 days.Patient did not have a similar disposable pen for novalin ge nph so he took only novorapid to control blood sugar.Patient took novorapid disposable pen while in las vegas then when went back to (b)(6) went back on his regular insulins.Action taken to novopen 4 (insulin delivery device) was not reported.Action taken to novopen 4 (insulin delivery device) was not reported.On (b)(6) 2018 the outcome for the event "high blood sugars" was recovered.The outcome for the event "plunger would not depress and unable to inject as the pens failed" was not reported.The outcome for the event "high glycosylated hemoglobin (a1c)" was not reported.

Event Description

Case description: investigational results: name: novopen® 4 - batch unknown.No investigation was possible, because neither sample nor batch number was available.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 investigational results updated as no investigation was possible, because neither sample nor batch number was available.Patient codes updated.Manufacturing comment updated.Narrative updated accordingly.Manufacturer's comment: 13-jul-2018: as the devices of novopen 4 have not been returned to novo nordisk a/s for investigation and 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 (b)(4).Continued: evaluation summary: 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: 7593477
• MDR Text Key: 110846504
• Report Number: 9681821-2018-00038
• 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
• Type of Report: Initial,Followup
• Report Date: 05/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2018
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NOVOLIN GE NPH PENFILL (INSULIN HUMAN); NOVORAPID PENFILL (INSULIN ASPART)
• Patient Outcome(s): Other
• Patient Age: 73 YR