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

Model Number N/A

Device Problems Failure to Deliver (2338); Device Operates Differently Than Expected (2913); Infusion or Flow Problem (2964); No Flow (2991)

Patient Problem Hyperglycemia (1905)

Event Date 05/12/2018

Event Type  Injury  

Event Description

High blood glucose up to 20 - 23 mmol/l [blood glucose increased].Insulin didn't go out through the new needles (microfine 4 mm) while the injector testing before injection [device issue].Suspected the injector of incorrect dosing [incorrect dose administered by device].Using insulin syringes [wrong technique in product usage process].Usually take out the cartridge from levemir flexpen and use it in combination with the suspect injector novopen echo [intentional product misuse].Case description: this serious spontaneous case from russian federation was reported by a health care professional as "high blood glucose up to 20 - 23 mmol/l" beginning on (b)(6) 2018, "insulin didn't go out through the new needles (microfine 4 mm) while the injector testing before injection" beginning on (b)(6) 2018, "suspected the injector of incorrect dosing" beginning on (b)(6) 2018, "using insulin syringes" beginning on (b)(6) 2018, "usually take out the cartridge from levemir flexpen and use it in combination with the suspect injector novopen echo" with an unspecified onset date, and concerned a (b)(6) male patient who was treated with novopen echo (insulin delivery device) from an unknown start date to (b)(6) 2018 due to "diabetes melitus type 1".(b)(6).Medical history included type 1 diabetes mellitus (since (b)(6) 2017).Concomitant products included - levemir flexpen(insulin detemir) solution for injection,.0024 mol/l.It was reported that patient usually take out the cartridge from levemir flexpen and use it in combination with the suspect injector novopen echo.They do it because of unavailability of 0.5 dose steps in the levemir penfill.On (b)(6) 2018, the patient's mother noticed that insulin did not pass through the new needles (microfine 4 mm) while the injector testing before injections.She suspected that injector delivered incorrect dose.Therefore on (b)(6) 2018, patient experienced high blood glucose up to 20 - 23 mmol/l.On (b)(6) 2018, the patient was switched from the suspected injector and used insulin syringes and on (b)(6) 2018; his blood glucose was reported as 5.3 mmol/l additionally it was observed that the patient got recovered from the event.Action taken to novopen echo was reported as product discontinued due to ae.On (b)(6) 2018 the outcome for the event "high blood glucose up to 20 - 23 mmol/l" was recovered.The outcome for the event "insulin didn't go out through the new needles (microfine 4 mm) while the injector testing before injection" was not reported.The outcome for the event "suspected the injector of incorrect dosing" was not reported.The outcome for the event "using insulin syringes" was not reported.The outcome for the event "usually take out the cartridge from levemir flexpen and use it in combination with the suspect injector novopen echo" was not reported.Investigational results: novopen echo batch fvg8996-1.The product was not returned for examination.A batch record review was found to be normal.The complaint has been registered in the novo nordisk complaint handling system.A field safety corrective action (fsca) has been performed for certain pen batches.A recall (novo nordisk (b)(4)) has been initiated on cartridge holders from the relevant affected pen batches.Manufacturer's comment: 15-jun-2018: as the device novopen echo has not been returned to novo nordisk a/s for investigation and only very limited information regarding the handling of suspected device is available, it is not possible to identify a clear root-cause of the experienced adverse event and thus find similar incidents to the one reported in (b)(4).A field safety corrective action (fsca) has been performed for certain pen batches.A recall (novo nordisk (b)(4)) has been initiated on cartridge holders from the relevant affected pen batches.Reporter comment: hcp's causality between the event and novopen echo is "possible".Evaluation summary: name: novopen echo, batch number: fvg8996-1.The product was not returned for examination.The complaint has been registered in the novo nordisk complaint handling system.

Event Description

Case description: investigational results: name: novopen echo.Batch : fvg8996-1.A batch record review was found to be normal.The batch documentation was reviewed.No abnormalities relating to the observed problem were found.A batch record review on cannot deliver was found to be normal.The electronic register was checked.Several mitigation codes were present which indicate use of a blocked or broken needle.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.Piston rod is difficult to retracted.Microscopic examination performed.Foreign matter on the piston rod.Dose button hard to depress and cannot deliver is caused by the use of a blocked needle.The dose accuracy was measured by weighing using a random penfill 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.Use a new needle for each injection.The needle should be mounted immediately before the injection.Always remove the used needle immediately after each injection and store the device without a needle attached.Otherwise, temperature fluctuations may cause leakage through the needle, resulting in a space between the rubber piston in the cartridge and the piston rod in the device.Furthermore, clogging of the needle may occur.The piston rod is difficult to retract.This is due to the piston rod being exposed to foreign dry matter, e.G.Dried insulin.The fault is caused by accidental damage during use of the device.The observed problem is caused by the use of a clogged or broken needle on the pen.The memory data in the device has revealed that the memory display has shown two lines (- -) after an attempted injection during use.After the injection to follow the 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.Since last submission, case was update with the following: investigation results updated.Manufacturer comment updated.Device codes updated.Manufacturer's comment: 23-aug-2018: no faults were found on the returned device novopen echo and during investigation it was observed that the piston rod was difficult to retract.This was due to the piston rod being exposed to foreign dry matter, e.G.Dried insulin.The fault is caused by accidental damage during use of the device.The observed problem is caused by the use of a clogged or broken needle on the pen.The memory data in the device revealed that the memory display has shown two lines (- -) after an attempted injection during use.The fault is caused by incorrect handling during use of the device/ user issue.Thus it is not possible to find similar incidents to the one reported in (b)(4).Evaluation summary: name: novopen echo.Batch number: fvg8996-1.A batch record review on xxx was found to be normal.The batch documentation was reviewed.No abnormalities relating to the observed problem were found.A batch record review on cannot deliver was found to be normal.The electronic register was checked.Several mitigation codes were present which indicate use of a blocked or broken needle.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.Piston rod is difficult to retracted.Microscopic examination performed.Foreign matter on the piston rod.Dose button hard to depress and cannot deliver is caused by the use of a blocked needle.The dose accuracy was measured by weighing using a random penfill 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.Use a new needle for each injection.The needle should be mounted immediately before the injection.Always remove the used needle immediately after each injection and store the device without a needle attached.Otherwise, temperature fluctuations may cause leakage through the needle, resulting in a space between the rubber piston in the cartridge and the piston rod in the device.Furthermore, clogging of the needle may occur.The piston rod is difficult to retract.This is due to the piston rod being exposed to foreign dry matter, e.G.Dried insulin.The fault is caused by accidental damage during use of the device.The observed problem is caused by the use of a clogged or broken needle on the pen.The memory data in the device has revealed that the memory display has shown two lines (- -) after an attempted injection during use.After the injection to follow the display will function normally again, if the injection needle is changed.

Event Description

Case description: on (b)(6) 2018, patient's hba1c (glycosylated hemoglobin) was 6.5%.The patient did not change from another pen to novopen echo.The force needed to inject felt higher than usual.Patient's mother was the operator of the device and has been trained by hcp in the use of the novopen.It was reported that insulin dose was changed (not specified) at the time of the event.Since last submission, case was update with the following: - reporter comment and description has been been updated as per new follow up.- narrative updated accordingly.- concomitant products updated.Reporter comment: hcp's causality between the event and novopen echo is "possible".Yes, the mother has been trained by hcp in the use of the novopen.But it has been very short training and all points related to injection technique hasn't been discussed.

• Brand Name: NOVOPEN ECHO
• Type of Device: INSULIN DELIVERY DEVICE
• Manufacturer (Section D): NOVO NORDISK A/S, MEDICAL SYSTEMS; hilleroed, ; DA
• MDR Report Key: 7654916
• MDR Text Key: 112886519
• Report Number: 9681821-2018-00041
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 06/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 185458
• Device Lot Number: FVG8996-1
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 00000-7/3/17-001-R
• Patient Sequence Number: 1
• Treatment: 1) LEVEMIR FLEXPEN (INSULIN DETEMIR); 1) LEVEMIR FLEXPEN (INSULIN DETEMIR); 2) LEVEMIR FLEXPEN (INSULIN DETEMIR); SOLUTION FOR INJECTION, .0024 MOL/L; SOLUTION FOR INJECTION, .0024 MOL/L; LEVEMIR FLEXPEN (INSULIN DETEMIR)
• Patient Outcome(s): Other
• Patient Age: 4 YR
• Patient Weight: 14