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

Model Number N/A

Device Problem No Flow (2991)

Patient Problems Abdominal Pain (1685); Hyperglycemia (1905); Hypoglycemia (1912)

Event Date 11/01/2019

Event Type  Injury  

Event Description

(related symptoms if any separated by commas).Pen no longer delivered insulin [device failure], hyperglycaemia [hyperglycaemia], piston rod stays inside the pen and high piston rod resistance [device malfunction], abdominal pain [abdominal pain], hypoglycaemia [hypoglycaemia].Case description: this serious spontaneous case from (b)(6) was reported by a consumer later confirmed by a pharmacist as "hyperglycaemia( hyperglycaemia)" beginning on (b)(6) 2019, "pen no longer delivered insulin (device failure)" beginning on (b)(6) 2019, "piston rod stays inside the pen and high piston rod resistance (device component malfunction)" beginning on (b)(6) 2019, "abdominal pain (abdominal pain)" with an unspecified onset date."hypoglycaemia (hypoglycaemia)" with an unspecified onset date, and concerned a (b)(6) male patient who was treated with novopen echo blue (insulin delivery device) from unknown start date and ongoing for "type 1 diabetes mellitus".Patient's weight: (b)(6), the patient's height and body mass index (bmi): not reported.Current condition: type 1 diabetes mellitus since (b)(6) 2019.Concomitant products included - levemir penfill (insulin detemir) solution for injection,.0024 mol/l (b)(6) 2019 to ongoing, novorapid (insulin aspart) solution for injection, 100 u/ml (b)(6) 2019 to ongoing.It was reported that the patient who was treated with novopen echo blue (batch number jvgp832-2) with levemir in cartridge.The spring of the pen stays inside, at the top of the pen.The push-button is very hard.The blue pen no longer delivered insulin levemir.Since 15 days (date: unspecified) the patient experienced strong hyperglycaemia with significant abdominal pain.The adverse event was considered as serious as severe hyperglycaemia with school dropout for 1 week and abdominal pain related to this hyperglycaemia.The dosage of levemir being poorly dosed.The change every 2 days of dosages (creating hypoglycaemia or hyperglycaemia - dosage deregulation).Situation improved only 1 week after the use of the new pen.The event reappeared when reused the pen.No lab data was available.The verification and the change of various needles was carried out since the reception of the pen in (b)(6) 2019.It was noted that the pen presented resistance to the injection compared to the second pen (red).The pharmacist pointed out that the sterile needles on the pen were changed, checked and correctly fixed.Batch number of novopen echo was jvgp832-2.Action taken to novopen echo was reported as change to new pen.The outcome for the event "hyperglycaemia (hyperglycaemia)" was recovering/resolving.The outcome for the event "pen no longer delivered insulin(device failure)" was not reported.The outcome for the event "piston rod stays inside the pen and high piston rod resistance(device component malfunction)" was not reported.The outcome for the event "abdominal pain (abdominal pain)" was recovering/resolving.The outcome for the event "hypoglycaemia (hypoglycaemia)" was recovering/resolving.Investigation results: name: novopen echo blue, batch number: jvgp832-2.The electronic register was checked.A mitigation code indicating that the pen has been used without any flow in the delivery system.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 piston rod did move forward and the function of the push button was found normal.The dose accuracy was measured by weighing using a random cartridge.The results were found to comply with specifications.The force required to depress the push-button was measured.The results were found to comply with specifications.There are some potential reasons why the delivery system might be unable to deliver the dialled dose but will act normal during testing.E.G.If the needle stays on the device between injections and dried preparation partly blocks the device or if the needle has not penetrated the rubber membrane because the needle was not screwed tightly on.This may cause you to feel much resistance when pressing the pushbutton or you are not able to depress the push button all the way.The directions given in the instruction leaflet on changing needles should be followed confirmed the memory data in the device has revealed that the memory display has shown two lines (- -) after an attempted injection during use.The observed problem is caused by the use of a clogged needle on the pen.After the injection to follow the memory display will function normally again, if the injection needle is changed to a new one.The fault is caused by incorrect handling during use of the device.This case was re-classified from nonserious to serious on 23-jan-2020 due to seriousness added upon follow-up.Manufacturer comment: upon investigation of the returned device, it was found that device function normally with new needle.The observed problem is caused by the use of a clogged needle on the pen.The fault is caused by incorrect handling during use of the device.Therefore, the report is evaluated as non-reportable incident reporter comment: the causal role was assessed as probable.No alternative aetiology existed.Evaluation summary: name: novopen® echo® bleu, batch number: jvgp832-2, the electronic register was checked.A mitigation code indicating that the pen has been used without any flow in the delivery system.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 piston rod did move forward and the function of the push button was found normal.The dose accuracy was measured by weighing using a random cartridge.The results were found to comply with specifications.The force required to depress the push-button was measured.The results were found to comply with specifications.There are some potential reasons why the delivery system might be unable to deliver the dialled dose but will act normal during testing.E.G.If the needle stays on the device between injections and dried preparation partly blocks the device or if the needle has not penetrated the rubber membrane because the needle was not screwed tightly on.This may cause you to feel much resistance when pressing the pushbutton or you are not able to depress the push button all the way.The directions given in the instruction leaflet on changing needles should be followed confirmed the memory data in the device has revealed that the memory display has shown two lines (- -) after an attempted injection during use.The observed problem is caused by the use of a clogged needle on the pen.After the injection to follow the memory display will function normally again, if the injection needle is changed to a new one.The fault is caused by incorrect handling during use of the device.

• Brand Name: NOVOPEN ECHO
• Type of Device: INSULIN DELIVERY DEVICE
• Manufacturer (Section D): NOVO NORDISK A/S, MEDICAL SYSTEMS; hilleroed, ; DA
• Manufacturer (Section G): NOVO NORDISK A/S; krogshoejvej 55; bagsvaerd 2880, ; DA
• Manufacturer Contact: p.o. box 846; plainsboro, NJ 08536 ; 8007276500
• MDR Report Key: 9738335
• MDR Text Key: 192416934
• Report Number: 9681821-2020-00011
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K123766
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial
• Report Date: 11/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 185458
• Device Lot Number: JVGP832-2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2019
• Date Manufacturer Received: 01/23/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/07/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 7 YR
• Patient Weight: 30