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

Model Number N/A

Device Problems Failure to Prime (1492); Infusion or Flow Problem (2964); Priming Problem (4040)

Patient Problem Hyperglycemia (1905)

Event Date 06/23/2018

Event Type  Injury  

Event Description

Increase of blood glucose level up to 15-20 mmol/l [blood glucose increased].During pre-injection check no drop of insulin was seen [device failure].Case description: this serious spontaneous case from (b)(6) was reported by a consumer as "increase of blood glucose level up to 15-20 mmol/l" beginning on (b)(6) 2018, "during pre-injection check no drop of insulin was seen" with an unspecified onset date, and concerned a (b)(6) -year-old male patient who was treated with novopen echo (insulin delivery device) from (b)(6) 2016 to (b)(6) 2018 due to "type 1 diabetes mellitus", novorapid penfill (insulin aspart) from (b)(6) 2016 and ongoing due to "type 1 diabetes mellitus" dose and frequency 9.50 u, tid (9.5 units per day: morning 4 iu - day 2.5-3 iu - evening 2.5 iu + additional injections, novofine 6mm (31g) (needle) from unknown start date due to "type 1 diabetes mellitus".Patient's height: 126 cm.Patient's weight: (b)(6).Patient's bmi (body mass index): 15.11699960.Medical history included type 1 diabetes mellitus (duration not reported).Concomitant products included - levemir(insulin detemir) solution for injection,.0024 mol/l.The patient used novopen echo with novorapid penfill.From (b)(6) 2018, the parents noticed that there was a systematic increase in blood sugar levels up to 15-20 mmol/l in the evening and at night.Following this, the parents noticed that during pre-injection there was no drop of insulin seen from the needle and changing the needle did not help reduce blood sugar.The patient changed his novopen echo to another new novopen echo.However, after changing the pen blood sugar levels normalized.Also, the patient used 1 novofine needle for 1 or 2 injections (usually 1) and sometimes left the needle on the pen between injections.The patient ensured that the needle was properly attached to the pen and attached the needle at 180 degree angle.The patient neither suspected lack of efficacy nor alleged novofine to the event.The patient was not trained in the use of device and the duration of use of novopen was 1.5 years.No force was needed to inject and the resistance was normal when attaching the needle.Action taken to novofine 6mm (31g) was not reported.Action taken to novopen echo was reported as product discontinued.Action taken to novorapid penfill was reported as no change.On (b)(6) 2018 the outcome for the event "increase of blood glucose level up to 15-20 mmol/l" was recovered.The outcome for the event "during pre-injection check no drop of insulin was seen" was not reported.On (b)(6) 2018, upon follow up the novofine needle was changed from suspect to concomitant and it will be updated in the case after resubmission.Company comment : the reported events are listed.This single case report is not considered to change the current knowledge of the safety profile of novorapid (insulin aspart).Reporter comment: alternative cause of high blood glucose is increase of the child's growth hormone at night.Evaluation summary: name: novopen® echo®, batch number: dv40090.The batch documentation was reviewed non-conformity-related documentation examined.No irregularities recorded therefore no further action.The batch documentation has been reviewed.Nothing abnormal was found.The electronic register was checked.No remarks.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 dose accuracy was measured by weighing using a random penfill cartridge.The results were found to comply with specifications.The product was found to be normal.During examination/test of the product it has not been possible to detect any irregularities.The product was found to be normal.

Event Description

Case description: this serious spontaneous case from russian federation was reported by a consumer as "increase of blood glucose level up to 15-20 mmol/l" beginning on (b)(6) 2018, "during pre-injection check no drop of insulin was seen" with an unspecified onset date, and concerned a 5-year-old male patient who was treated with novopen echo (insulin delivery device) from (b)(6) 2016 to (b)(6) 2018 due to "type 1 diabetes mellitus" and novorapid penfill (insulin aspart) from (b)(6) 2016 and ongoing due to "type 1 diabetes mellitus" (dose and frequency 9.50 u, tid (9.5 units per day: morning 4 iu - day 2.5-3 iu - evening 2.5 iu + additional injections.) concomitant products included - levemir(insulin detemir), novofine 6mm (31g) (needle).Action taken to novopen echo was reported as product discontinued.Action taken to novorapid penfill was reported as no change.Investigation result: name: novopen® echo®, batch number: dv40090.The batch documentation was reviewed non-conformity-related documentation examined.No irregularities recorded therefore no further action.The batch documentation has been reviewed.Nothing abnormal was found.The electronic register was checked.No remarks.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 dose accuracy was measured by weighing using a random penfill cartridge.The results were found to comply with specifications.The product was found to be normal.During examination/test of the product it has not been possible to detect any irregularities.The product was found to be normal.Name : novorapid® penfill® 100 u/ml - batch number :unknown.No investigation was possible, because neither sample nor batch number was available.Since last submission, the case has been updated with the below information: novofine 6mm (31g) changed from suspect to concomitant.Device component code added.Reporter comment updated.Investigation results updated.Manufacturer comment updated.Narrative updated accordingly.Manufacturer's comment / company comment : 10-aug-2018: since no faults were found on the returned device novopen echo and only very limited information regarding the patients handling of the suspected device is reported in the case,it is not possible to elucidate a clear root cause for the experienced adverse event and thus not possible to find similar incidents to the one reported in (b)(4).The reported events are listed.This single case report is not considered to change the current knowledge of the safety profile of novorapid (insulin aspart).Reporter comment: alternative cause of high blood glucose is increase of the child's growth hormone at night.Reporter causality of the event (increase of blood glucose level up to 15-20 mmol/l) with respect to novorapid penfill was unlikely.Evaluation summary: name: novopen® echo®, batch number: dv40090.The batch documentation was reviewed.Non-conformity-related documentation examined.No irregularities recorded therefore no further action.The batch documentation has been reviewed.Nothing abnormal was found.The electronic register was checked.No remarks.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 dose accuracy was measured by weighing using a random penfill cartridge.The results were found to comply with specifications.The product was found to be normal.During examination/test of the product it has not been possible to detect any irregularities.The product was found to be normal.

• Brand Name: NOVOPEN ECHO
• Type of Device: INSULIN DELIVERY DEVICE
• Manufacturer (Section D): NOVO NORDISK A/S, MEDICAL SYSTEMS; hilleroed, ; DA
• MDR Report Key: 7723764
• MDR Text Key: 115189709
• Report Number: 9681821-2018-00053
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• PMA/PMN Number: K123766
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 06/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/12/2019
• Device Model Number: N/A
• Device Catalogue Number: 185458
• Device Lot Number: DV40090
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 1) LEVEMIR (INSULIN DETEMIR); 1) NOVOFINE 6MM (31G) (NEEDLE) N/A; 2) LEVEMIR (INSULIN DETEMIR); SOLUTION FOR INJECTION, .0024 MOL/L
• Patient Outcome(s): Other
• Patient Age: 5 YR
• Patient Weight: 24