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

Model Number N/A

Device Problem Mechanical Problem (1384)

Patient Problem Hypoglycemia (1912)

Event Date 06/26/2019

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas); severe hypoglycemia [hypoglycaemia]; device was not working properly, injection button is hard to depress; [device malfunction]; needle is kept attached to the pen [product storage error].Case description: this serious spontaneous case from (b)(6) was reported by a consumer as "severe hypoglycemia" beginning on (b)(6) 2019, "device was not working properly, injection button is hard to depress" with an unspecified onset date, "needle is kept attached to the pen" 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 "device therapy" and novopen 4 (insulin delivery device) from unknown start date due to "device therapy".Patient's height, weight and body mass index (bmi) were not reported.Medical history was not provided.Concomitant products included - mixtard 30 penfill (insulin human) suspension for injection, 100 iu/ml, actrapid penfill (insulin human) solution for injection, 100 iu/ml on (b)(6) 2019, patient experienced an episode of severe hypoglycemia and emergency medical team (emt) was called for assistance.An emt's nurse measured a blood glucose level of 30 mg/dl with their device.The nurse also measured the patient blood glucose level with the patient's device and the measured level was 70mg/dl.It was reported that nurse said the patient's device was not working properly.The patient used mixtard 30 penfil in the morning (24 u) and at night (26 u).Patient has the indication to administer actrapid penfill before lunch (5 u).It was also reported that novopen 4 silver and novopen 4 blue were not working properly, injection button was hard to depress.The patient said his values are now normal and that the last measured blood glucose level was 180 mg/dl.The patient on follow up confirmed that he is recovering and the blood glucose values were measured to be 115mg/dl.The patient said that never did an additional administration, never performing two consecutive administrations.The patient could not confirm regarding the needles, regarding how he uses them, the patient said that sometimes he uses the same needle more than once and in these situations the needle is kept attached to the pen between injections batch number was reported.On (b)(6) 2019 the outcome for the event "severe hypoglycemia" was recovered.The outcome for the event "device was not working properly, injection button is hard to depress" was not reported.The outcome for the event "needle is kept attached to the pen" was not reported.

Event Description

Severe hypoglycemia [hypoglycaemia].Device was not working properly, injection button is hard to depress [device malfunction].Administered actrapid penfill instead of mixtard 30 penfill at night [wrong product administered].Needle is kept attached to the pen [product storage error].Case description: this serious spontaneous case from portugal was reported by a consumer as "severe hypoglycemia" beginning on (b)(6) 2019, "device was not working properly, injection button is hard to depress" with an unspecified onset date, "administered actrapid penfill instead of mixtard 30 penfill at night" with an unspecified onset date, "needle is kept attached to the pen" with an unspecified onset date, and concerned a 76-year-old male patient who was treated with novopen 4 (insulin delivery device) from unknown start date due to "device therapy" and novopen 4 (insulin delivery device) from unknown start date due to "device therapy", mixtard 30 penfill (insulin human) from unknown start date due to an unknown indication (dose and frequency 50 iu, qd (24-0-26) ), actrapid penfill (insulin human) from unknown start date due to an unknown indication (dose and frequency 5 iu, qd (lunch) ).Concomitant products were not reported.The patent informed that it was possible that he might have administered the wrong insulin at night, specifically that he might have administered actrapid penfill instead of mixtard 30 penfill.On (b)(6) 2019 the outcome for the event "severe hypoglycemia" was recovered.The outcome for the event "device was not working properly, injection button is hard to depress" was not reported.The outcome for the event "administered actrapid penfill instead of mixtard 30 penfill at night" was not reported.The outcome for the event "needle is kept attached to the pen" was not reported.Investigational results: name: novopen® 4 silver, batch number: evg2802-4.Visual and functional examinations were performed.The device was tested with a random cartridge and a novo nordisk needle was mounted.During testing it was possible to deliver preparation from the cartridge.The dose accuracy was measured by weighing using a random cartridge.The results were found to comply with specifications.During examination/test of the product it has not been possible to detect any irregularities.The product was found to be normal.Name: novopen® 4 silver, batch number: sv40582.Visual and functional examinations were performed.The device was tested with a random cartridge and a novo nordisk needle was mounted.During testing it was possible to deliver preparation from the cartridge.However, the pen operates in jerks and cannot deliver properly.The dose accuracy was measured by weighing using a random cartridge.The results were found to comply with specifications.During examination/test of the product it has not been possible to detect any irregularities.The product was found to be normal.Since last submission, the following has been updated: -mixtard 30 penfill and actrapid penfill added as suspects; -new event of 'wrong drug administered' added; -investigational results added; -manufacturer's comment updated; -narrative updated accordingly.Manufacturer's comment: 29-jul-2019: upon investigation of the returned devices (novopen 4 silver, batch no.Evg2802-4 and sv40582) one device was found to function normally.The other pen operates in jerks; but delivers insulin normally.Patient used to reuse needles and store the device with needle attached which could have affected the normal functioning of the pens.The observed problem (device malfunction) is due to incorrect handling during use.The reported events (hypoglycaemia and wrong drug administered) are listed.Patient injected actrapid penfill instead of mixtard 30 penfill could have led to hypoglycaemia.Elderly age of the patient is a significant confounding factor for the error.This single case report is not considered to change the current knowledge of the safety profile of mixtard 30 penfill and actrapid penfill.H3 continued: evaluation summary.Name: novopen® 4 silver.Batch number: sv40582.Visual and functional examinations were performed.The device was tested with a random cartridge and a novo nordisk needle was mounted.During testing it was possible to deliver preparation from the cartridge.However, the pen operates in jerks and cannot deliver properly.The dose accuracy was measured by weighing using a random cartridge.The results were found to comply with specifications.During examination/test of the product it has not been possible to detect any irregularities.The product was found to be normal.

• Brand Name: NOVOPEN 4
• Type of Device: INSULIN DELIVERY DEVICE
• Manufacturer (Section D): NOVO NORDISK A/S, MEDICAL SYSTEMS; hilleroed, ; DA
• MDR Report Key: 8826140
• MDR Text Key: 152206535
• Report Number: 9681821-2019-00046
• 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
• Type of Report: Initial,Followup
• Report Date: 06/27/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2019
• 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: SV40582
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2019
• Date Manufacturer Received: 07/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACTRAPID PENFILL (INSULIN HUMAN).; MIXTARD 30 PENFILL (INSULIN HUMAN).; ACTRAPID PENFILL (INSULIN HUMAN); MIXTARD 30 PENFILL (INSULIN HUMAN)
• Patient Outcome(s): Other
• Patient Age: 76 YR