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

Model Number N/A

Device Problems Complete Blockage (1094); Failure to Deliver (2338); No Flow (2991)

Patient Problem Hyperglycemia (1905)

Event Date 10/18/2021

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas).Hyperglycemia [hyperglycaemia].Blocked pen [device occlusion].Pen was blocked and the product did not come out [device failure].3 missed injections (pen was blocked and the product did not come out) [drug dose omission by device].Case description: this serious spontaneous case from (b)(6) was reported by a pharmacist as "hyperglycemia(hyperglycemia)" beginning on (b)(6) 2021, "blocked pen(device occlusion)" beginning on (b)(6) 2021, "pen was blocked and the product did not come out(device failure)" beginning on (b)(6) 2021, "3 missed injections (pen was blocked and the product did not come out)(drug dose omission by device)" beginning on (b)(6) 2021, and concerned a (b)(6) years old male patient who was treated with novopen echo (insulin delivery device) from unknown start date for "device therapy", the patient's height, weight and body mass index was not reported.Medical history was not provided.It was reported that on (b)(6) 2021, the pen was blocked and the product did not come out.The patient had missed 3 daily doses and was taken to the emergency room for hyperglycemia.The pen was bought recently.Batch numbers: novopen echo: kvgy777.Action taken to novopen echo was reported as unknown.The outcome for the event "hyperglycemia(hyperglycemia)" was unknown.The outcome for the event "blocked pen(device occlusion)" was unknown.The outcome for the event "pen was blocked and the product did not come out(device failure)" was unknown.The outcome for the event "3 missed injections (pen was blocked and the product did not come out)(drug dose omission by device)" was unknown.

Event Description

Case description: investigation result: novopen echo rouge - batch kvgy777.A visual examination and functional testing were performed.It was not possible to observe the alleged fault.All mechanical functions were found to be normal.The electronic register was checked.The memory data in the device revealed that a number of attempted injections did not turn out to be successful and that this was caused by no flow in the delivery system (e.G.The use of a clogged needle on the pen during use).This also made the memory display warn the user by showing two lines (- -) after the attempted injections.In the injection to follow the attempted but faulty injection the pen will function as normal again, if a new injection needle is mounted on the pen immediately before the injection.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.The observed problem is caused by unintended use of the device.Since last submission case has been updated with following, investigation result updated.Device tab, eu/ca tab and device addendum tab updated.Narrative updated accordingly final manufacturer's comment: 15-dec-2021: upon investigation of the returned novopen echo, it was not possible to observe the alleged fault.All mechanical functions were found to be normal.The memory display showed - - (two lines) after injection.The observed problem does not influence the mechanical functions of the pen.The observed problem was caused by interference from foreign matter entering the pen and is due to accidental handling during use or by the use of a clogged needle on the pen.The patient will not receive any insulin and could experience a hyperglycemic event.The fault is caused by incorrect handling during use of the device.H3 continued: evaluation summary.Investigation result: novopen echo rouge - batch kvgy777.A visual examination and functional testing were performed.It was not possible to observe the alleged fault.All mechanical functions were found to be normal.The electronic register was checked.The memory data in the device revealed that a number of attempted injections did not turn out to be successful and that this was caused by no flow in the delivery system (e.G.The use of a clogged needle on the pen during use).This also made the memory display warn the user by showing two lines (- -) after the attempted injections.In the injection to follow the attempted but faulty injection the pen will function as normal again, if a new injection needle is mounted on the pen immediately before the injection.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.The observed problem is caused by unintended use of the device.

Event Description

Case description: this serious spontaneous case from france was reported by a pharmacist as "hyperglycemia(hyperglycemia)" beginning on (b)(6) 2021, "blocked pen(device occlusion)" beginning on (b)(6) 2021, "pen was blocked and the product did not come out(device failure)" beginning on (b)(6) 2021, "3 missed injections (pen was blocked and the product did not come out)(drug dose omission by device)" beginning on (b)(6) 2021, and concerned a 11 years old male patient who was treated with novopen echo (insulin delivery device) from unknown start date for "device therapy".Patient's height: 134 cm.Patient's weight: 36 kg.Patient's body mass index (bmi): 20.04900870.Dosage regimens: novopen echo: allergy: allergy.Concomitant products included - novorapid(insulin aspart) solution for injection, 100 iu/ml (b)(6) 2021 to unk and (b)(6) 2021 to unk, tresiba(insulin degludec) solution for injection (b)(6) 2021 to unk, aerius [ebastine](ebastine) --/--/2017 to unk, flixotide(fluticasone propionate) --/--/2017 to unk.On (b)(6) 2021, the pen was blocked and the product did not come out.The patient had missed 3 daily doses resulted in hyperglycemia without acetone.High agitation, detection of hyperglycemia by the sensor and emergency medical services were called and then the patient was hospitalized in the paediatric emergency room and as treatment patient received novorapid.Regulation of glycemia by the emergency service and then patient was discharged.It was reported that purging has well done but the injection was not successful and patient not changed treatment within the last 3 months.On (b)(6) 2021 the outcome for the event "hyperglycemia(hyperglycemia)" was recovered.The outcome for the event "blocked pen(device occlusion)" was unknown.The outcome for the event "pen was blocked and the product did not come out(device failure)" was unknown.The outcome for the event "3 missed injections (pen was blocked and the product did not come out)(drug dose omission by device)" was unknown.Since last submission case has been updated with following, -height, weight and medical history added.-concomitant added.-hospitalization date, event onset date added.-outcome added.-causality added.Narrative updated accordingly.References included: reference type: e2b company number.Reference id#: (b)(4).Reference notes: e2b company number reference type: mw 3500a mfr.Rpt.#.Reference id#: 9681821-2021-00071.Reference notes: medwatch 3500a mfr.Report number.Reporter comment: - the product was in its original packaging.- the error was committed when the product was administered.

• 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 2880
• Manufacturer Contact: p.o. box 846; plainsboro,, NJ 08536 ; 8007276500
• MDR Report Key: 12827418
• MDR Text Key: 280872571
• Report Number: 9681821-2021-00071
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K123766
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date: 10/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/30/2022
• Device Model Number: N/A
• Device Catalogue Number: 185459
• Device Lot Number: KVGY777
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2020
• 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
• Treatment: AERIUS [EBASTINE] (EBASTINE); FLIXOTIDE (FLUTICASONE PROPIONATE); NOVORAPID (INSULIN ASPART) SOLUTION FOR INJECTION; NOVORAPID (INSULIN ASPART) SOLUTION FOR INJECTION; TRESIBA (INSULIN DEGLUDEC)
• Patient Outcome(s): Required Intervention; Hospitalization; Other
• Patient Age: 11 YR
• Patient Sex: Male
• Patient Weight: 36 KG