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

Model Number N/A

Device Problems Device Expiration Issue (1216); Connection Problem (2900); Infusion or Flow Problem (2964)

Patient Problem Hyperglycemia (1905)

Event Type  Injury  

Event Description

High blood sugar levels up to 34 mmol/l.[blood glucose increased].Patient not been getting correct dose of insulin [incorrect dose administered by device].Faulty pen: cartridge holder has cracked and black screw thing that pushes the insulin through the needle and into your body doesn't work [device issue].Case description: this serious spontaneous case from (b)(6) was reported by a consumer as "high blood sugar levels up to 34 mmol/l." with an unspecified onset date, "patient not been getting correct dose of insulin" with an unspecified onset date, "faulty pen: cartridge holder has cracked and black screw thing that pushes the insulin through the needle and into your body doesn't work" with an unspecified onset date, and concerned an (b)(6) years old male patient who was treated with novopen 4 (insulin delivery device) from an unknown start date and ongoing due to "diabetes mellitus" and novorapid penfill (insulin aspart) (dose, frequency, & route used: unk, unknown therapy dates: ongoing) from an unknown start date and ongoing due to "diabetes mellitus".Patient's height, weight and body mass index (bmi) were not reported.Medical history included diabetes mellitus (type and duration: not reported).It was reported that the patient had a faulty pen; cartridge holder of novopen 4 had cracked.Also, black screw thing that pushed the insulin through the needle and into patient's body did not work the patient believed that because of faulty pen, he had not been getting correct dose of insulin.On an unknown date, the patient had high blood sugar levels up to 34 mmol/l.The patient reported that he had this pen for many years and it had really worked hard to keep him alive.Action taken to novopen 4 was not reported.Action taken to novorapid penfill was reported as no change.The outcome for the event "high blood sugar levels up to 34 mmol/l." was not yet recovered.The outcome for the event "patient not been getting correct dose of insulin" was not reported.The outcome for the event "faulty pen: cartridge holder has cracked and black screw thing that pushes the insulin through the needle and into your body doesn't work" was not reported.No further information available.Company comment: the reported events are listed.This single case report is not considered to change the current knowledge of the safety profile of novorapid.

Event Description

Case description: investigation result: product name: novopen 4 silver batch number: yug0383 pen received without cartridge holder.Not possible to test.It is not possible to investigate the returned sample comprehensively.Visual and functional examinations were performed.The piston washer was whole and seated as intended on the piston rod.Furthermore, it had no damages.The device was tested with a random cartridge holder and a random cartridge holder and 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 holder and random pen fill 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: novorapid® penfill® 3ml, batch number: unknown no investigation was possible, because neither sample nor batch number was available.Since last submission, the case has been updated with the following: investigation results updated, manufacturer's comment updated, device codes, narrative updated accordingly.Manufacturer's comment/company comment: 13-apr-2018: since no faults were found on the returned device novopen 4 and only very limited information regarding the patients handling of the suspected device is reported in the case, it is not possible to elucidate a clear root cause for the experienced adverse event and thus not possible to find similar incidents to the one reported in (b)(4).The reported events are listed.This single case report is not considered to change the current knowledge of the safety profile of novorapid (insulin aspart).Evaluation summary: investigation result: product name: novopen 4 silver batch number: yug0383 pen received without cartridge holder.Not possible to test.It is not possible to investigate the returned sample comprehensively.Visual and functional examinations were performed.The piston washer was whole and seated as intended on the piston rod.Furthermore, it had no damages.The device was tested with a random cartridge holder and a random cartridge holder and 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 holder and random pen fill 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: 7379519
• MDR Text Key: 103777204
• Report Number: 9681821-2018-00023
• 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: 03/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/16/2015
• Device Model Number: N/A
• Device Catalogue Number: 185490
• Device Lot Number: YUG0383
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 81 YR