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

Model Number N/A

Device Problem Device Handling Problem (3265)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912)

Event Date 02/24/2024

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas) blood glucose level increased [blood glucose increased] blood glucose level decreased [blood glucose decreased] administration of wrong insulin (fiasp instead of tresiba) [wrong product administered] due to mixing up of the novo pen echo pens, which were both the same red color) [product packaging confusion] case description: this serious spontaneous case from poland was reported by a consumer as "blood glucose level increased(blood glucose increased)" beginning on (b)(6) 2024, "blood glucose level decreased(blood glucose decreased)" beginning on (b)(6) 2024, "administration of wrong insulin (fiasp instead of tresiba)(wrong product administered)" beginning on (b)(6) 2024, "due to mixing up of the novo pen echo pens, which were both the same red color)(look alike packaging)" beginning on (b)(6) 2024, and concerned a 7 years old male patient who was treated with novopen echo plus (insulin delivery device) from unknown start date for "type 1 diabetes mellitus", fiasp penfill (insulin aspart) (dose, frequency & route used-2,5 u, subcutaneous) from (b)(6) 2024 and ongoing for "type 1 diabetes mellitus", event abated after use stopped or dose reduced- doesn't apply and event reappeared after reintroduction- doesn't apply, tresiba penfill 100 u/ml (insulin degludec) (dose, frequency & route used- unk, subcutaneous) from unknown start date for "type 1 diabetes mellitus".Patient's height: 145 cm patient's weight: 30 kg patient's bmi: 14.26872770.Dosage regimens: novopen echo plus: not reported to not reported, (b)(6) 2024 to not reported; fiasp penfill: (b)(6) 2024 to not reported (dosage regimen ongoing); tresiba penfill 100 u/ml: current condition: diabetes mellitus type 1(started from (b)(6) 2024) historical condition: blood glucose increase historical drug: novorapid, lantus procedure: hospitalization.(discharged on (b)(6) 2024) on an unknown date the patient was admitted to a hospital due to increased blood glucose level (blood glucose) up to 500 mg/dl.The patient spent in a hospital 10 days during hospitalization type 1 diabetes mellitus was diagnosed and insulins novo rapid and lantus were introduced to a patient.While discharging home from the hospital on (b)(6) 2024 the patient started taking insulins fiasp and tresiba.On (b)(6) 2024, the patient blood glucose level was increased and the patient was hospitalized on (b)(6) 2024 after his mother injected him 2,5 u of incorrect insulin (i.E.Fiasp instead of tresiba) due to mixing up of the novo pen echo pens, which were both the same red color.The blood glucose level decreased and the patient was hospitalized.On (b)(6) 2024 blood glucose level (blood glucose)subsequently increased up to 250 mg/dl.The patient has not been taking other medications.While discharging they were equipped with 2 pens and one of them was not compatible with novo nordisk insulin.When they were at home they noticed this incompatibility and returned back to a hospital.2 days after discharging home they received second pen, this time compatible with novo nordisk insulin.Batch numbers: novopen echo plus: nvgad93, nvgad93 fiasp penfill: asku tresiba penfill 100 u/ml: asku action taken to novopen echo plus was reported as no change.Action taken to fiasp penfill was reported as no change.Action taken to tresiba penfill 100 u/ml was not reported.The outcome for the event "blood glucose level increased(blood glucose increased)" was recovered.The outcome for the event "blood glucose level decreased(blood glucose decreased)" was recovered.On (b)(6) 2024 the outcome for the event "administration of wrong insulin (fiasp instead of tresiba)(wrong product administered)" was recovered.On (b)(6) 2024 the outcome for the event "due to mixing up of the novo pen echo pens, which were both the same red color)(look alike packaging)" was recovered.References included: reference type: e2b company number reference id#: (b)(4).Reference notes:.

• Brand Name: NOVOPEN ECHO PLUS
• Type of Device: INSULIN DELIVERY DEVICE
• Manufacturer (Section D): NOVO NORDISK A/S; bagsvaerd,, ; 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: 18958146
• MDR Text Key: 338321560
• Report Number: 9681821-2024-00047
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• Reporter Country Code: PL
• PMA/PMN Number: K123766N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: N/A
• Device Lot Number: NVGAD93
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/03/2024
• Date Device Manufactured: 02/26/2023
• 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): Hospitalization
• Patient Age: 7 YR
• Patient Sex: Male
• Patient Weight: 30 KG