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

Model Number N/A

Device Problems Defective Component (2292); Inaccurate Delivery (2339); Mechanical Jam (2983)

Patient Problem Hyperglycemia (1905)

Event Date 02/10/2023

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas).Hyperglycemia [hyperglycaemia].The plunger get jammed [device mechanical issue].The plunger was no longer touching the cartridge and there was a gap between the 2 [device issue].Suspicion of an incomplete dose because the pen is defective [device delivery system issue].Suspicious an injection of insulin defect [suspected product quality issue].Case description: this serious spontaneous case from france was reported by a pharmacist as "hyperglycemia(hyperglycemia)" beginning on (b)(6) 2023, "the plunger get jammed(device mechanical jam)" beginning on (b)(6) 2023, "the plunger was no longer touching the cartridge and there was a gap between the 2(device component issue)" beginning on (b)(6) 2023, "suspicion of an incomplete dose because the pen is defective(inaccurate delivery by device)" beginning on (b)(6) 2023, "suspicious an injection of insulin defect(suspected product quality issue)" beginning on (b)(6) 2023, and concerned a 70 years old male patient who was treated with novopen echo (insulin delivery device) from unknown start date for "device therapy", novorapid penfill (insulin aspart) (dose, frequency & route used- 25 to 30 units per day) from unknown start date for "type 1 diabetes mellitus".Patient's height: 168 cm.Patient's weight: 68 kg.Patient's bmi: 24.09297050.Dosage regimens: null.Novopen echo: null.Novorapid penfill: null.Current condition: type 1 diabetes mellitus(since 1962) , blood cholesterol abnormal.Concomitant products included - atorvastatin [atorvastatin], uvedose(cholecalciferol), toujeo(insulin glargine) on (b)(6) 2023, patient had a problem with her red novopen echo pen.Patient reported pen has jammed and when the patient changed the cartridge, the plunger was no longer touching the cartridge.There was a gap between the two.Patient purged several times, everything was back to normal, but when he gave his injection, his blood sugar went up(hyperglycemia).The patient has unlocked it but glycemias have become high giving rise to suspicious an injection of insulin defect.The issue has persisted despite the increase of the number units of insulin injected.Patient thinks that she didn't get his full dose.Patient fasting glycemia was 2.59g/l and post prandial glycemia 3.53 g/l he had to take his pre-filled pen to do his injection after his blood sugar returned to normal.On (b)(6) 2023 or (b)(6) 2023, the patient was full recovered, when they changed to a new pen.Batch numbers: novopen echo: lvg5e29.Novorapid penfill: mr7en65.Action taken to novopen echo was reported as unknown.Action taken to novorapid penfill was not reported.On (b)(6) 2023 the outcome for the event "hyperglycemia(hyperglycemia)" was recovered.The outcome for the event "the plunger get jammed(device mechanical jam)" was not reported.The outcome for the event "the plunger was no longer touching the cartridge and there was a gap between the 2(device component issue)" was unknown.On (b)(6) 2023 the outcome for the event "suspicion of an incomplete dose because the pen is defective(inaccurate delivery by device)" was recovered.The outcome for the event "suspicious an injection of insulin defect(suspected product quality issue)" was not reported.

Event Description

Case description: investigation result name: novopen® echo® rouge, batch number: lvg5e29 a visual examination of the returned product was performed.The device was returned with the cartridge from this case mounted.The electronic register was checked.The register showed mitigation codes.Visual examination and functional testing were performed.The piston rod and its functions were found to be normal.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 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 was due to accidental handling during use.Novorapid® penfill® 100 u/ml, batch number:mr7en65 a visual examination of the returned product was performed.It was not possible to test the cartridge for inaccuracy.The returned cartridge was tested for delivery with a novopen® echo® and a novo nordisk needle.During testing it was possible to deliver preparation chemical analysis of the returned sample was performed.The result was within acceptable limits.During examination of the product, no irregularities related to the complaint were detected.Since last submission, this case has been updated with the following investigation result added imdrf code added e2b report duplicate added narrative updated accordingly references included: reference type: e2b company number reference id#: (b)(4) reference notes: reference type: mw 3500a mfr.Rpt.# reference id#: 9681821-2023-00052 reference notes: medwatch 3500a mfr.Report number reference type: e2b report duplicate reference id#: (b)(4) reference notes: ansm (national agency for the safety of medicine and health products), fra final manufacturer's comment: 02-may-2023: the suspected device (novopen echo) with a cartridge mounted, returned to novo nordisk for evaluation.Visual examination was normal.The dose accuracy was measured by weighing using a random cartridge.The results were found to comply with specifications.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 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.The user can detect the fault and will abstain from further use of the display functionality.The user can still use the pen and it is judged that the fault has no impact on the patient's health or treatment.H3 continued: evaluation summary name: novopen® echo® rouge, batch number: lvg5e29 a visual examination of the returned product was performed.The device was returned with the cartridge from this case mounted.The electronic register was checked.The register showed mitigation codes.Visual examination and functional testing were performed.The piston rod and its functions were found to be normal.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 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 was due to accidental handling during use.

• 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: 16724049
• MDR Text Key: 313169500
• Report Number: 9681821-2023-00052
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• 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
• Report Date: 02/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 10/04/2023
• Device Model Number: N/A
• Device Catalogue Number: 185459
• Device Lot Number: LVG5E29
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2021
• 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: ATORVASTATINE [ATORVASTATIN] ONGOING; TOUJEO (INSULIN GLARGINE) ONGOING.; UVEDOSE (COLECALCIFEROL) ONGOING.
• Patient Outcome(s): Other
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 68 KG