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

Model Number N/A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Hyperglycemia (1905)

Event Date 10/01/2015

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas hyperglycemia resulting from difficulties in the use of the two pens [hyperglycaemia] novopen echo red dose selector didn't return to zero and novopen echo blue was difficult to make the purge [device issue] case description: this serious spontaneous case from france was reported by a pharmacist as "hyperglycemia resulting from difficulties in the use of the two pens" and "novopen echo red dose selector didn't return to zero and novopen echo blue was difficult to make the purge" both beginning on an unknown date in (b)(6) 2015 and concerned an (b)(6) year-old female patient who used novopen echo red (insulin delivery device) and novopen echo blue (insulin delivery device) both from an unknown start date in (b)(6) 2015 for type 1 diabetes mellitus.Medical history included type 1 diabetes mellitus (since 2015).Concomitant products included - novorapid penfill (insulin aspart), insulatard penfill (insulin human).On unknown date in (b)(6) 2015, the patient started the treatment with novorapid penfill (twice daily) with novopen echo red and insulatard penfill (twice daily) with novopen echo blue.It was reported, that the patient's blood glucose level was not balanced for one week and the patient experienced hyperglycemia due to difficulties in the use of the two pens.For novopen echo red, the dose selector didn't return towards zero.For novopen echo blue, it was difficult to make the purge.Lab data was reported for patient in g/l as: on (b)(6) 2015, the patient's blood glucose level was 1.37 at 7am, 2.40 at noon, 2.50 at 7pm and 2.59 at 11pm and test for ketones in urine was (b)(6).On (b)(6) 2015, the fasting glycaemia (07:03 am) was 1.54, the glycaemia before meal (04:07 pm) was 2.61 and the glycaemia after meal (11:03 pm) was 2.94.On (b)(6) 2015, the fasting glycaemia (07:04 am) was 1.19, the glycaemia before meal (04:02 pm) was 1.89 and the glycaemia after meal (11:15 pm) was 1.44.On (b)(6) 2015, the fasting glycaemia (07:23 am) was 1.57, the glycaemia before meal (12:51 am) was 1.75 and the glycaemia after meal (11:12 pm) was 3.74 with the insulin injection (1 iu) at 11:15pm.On (b)(6) 2015, the fasting glycaemia (07:03 am) was 2.74, with insulin injection (1 iu) at 12:16 am, the glycaemia before meal (12:16 am) was 3.08 and the glycaemia after meal (11:13 pm) was 0.99.On (b)(6) 2015, the fasting glycaemia (07:03 am) was 2.74 with insulin injection (1 iu) at 12:16 am, the glycaemia before meal (04:13 pm) was 3.75 with the insulin injection (1 iu) at 04:15pm and the glycaemia after meal was 1.13 with the insulin injection (1.5 iu) at 10:07pm.On (b)(6) 2015, the fasting glycaemia (07:13 am) was 2.11, the glycaemia before meal (12:01 pm) was 2.41 and the glycaemia after meal (11:20 pm) was 3.28 with the insulin injection (1 iu) at 23:21pm.On (b)(6) 2015, the fasting glycaemia (07:00 am) was 0.97, the glycaemia before meal (04:30 pm) was 1.41 and the glycaemia after meal (11:04 pm) was 1.82.On (b)(6) 2015, the fasting glycaemia (07:16 am) was 1.64, the glycaemia before meal (04:26 pm) was 1.99 and the glycaemia after meal (11:01 pm) was 0.75.On an unknown date (reported as since sunday evening), the patient received a new novopen echo red with a new cartridge and the blood glucose level were normal.For novopen echo blue, the piston rod came down.It was necessary to purge with more units to obtain a product output.Action taken to novopen echo red and novopen echo blue was not reported.The outcome for the event "hyperglycemia resulting from difficulties in the use of the two pens" was reported as recovered.The outcome for the event "novopen echo red dose selector didn't return to zero and novopen echo blue was difficult to make the purge" was not reported.Investigation results novopen (tm)echo (tm)rouge - batch (b)(4).Visual and functional examinations were performed.The device was tested with a random cartridge and a novo nordisk needle was mounted.All mechanical functions are normal including the piston rod function.The dose accuracy was measured by weighing using a random cartridge.The results were found to comply with specifications.The electronic register was checked.A batch trend report has been created.Nothing abnormal was found.Confirmed: the memory data in the device revealed that the memory display has shown two lines (- -) after attempted injections during use.The observed problem is caused by the use of a clogged needle on the pen.After the injection to follow the display and pen 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.Novopen (tm)echo (tm)bleu - batch (b)(4).Visual and functional examinations were performed.The device was tested with a random cartridge and a novo nordisk needle was mounted.All mechanical functions are normal including the piston rod function.The dose accuracy was measured by weighing using a random cartridge.The results were found to comply with specifications.The electronic register was checked.Confirmed: the memory data in the device revealed that the memory display has shown two lines (- -) after attempted injections during use.The observed problem is caused by the use of a clogged needle on the pen.After the injection to follow the display and pen 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.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.Finally, priming to expel air must always be performed before each injection, as stated in the package leaflet.Final manufacturer's comment: (b)(6) 2015: investigation results of both pens showed that the memory data in the device revealed that the memory display has shown two lines (- -) after attempted injections during use.The observed problem is caused by the use of a clogged needle on the pen.After the injection to follow the display and pen will function normally again, if the injection needle is changed to a new one.The fault is likely caused by incorrect handling during use of the device.However, as only very limited information regarding the patient's handling of suspected pens 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).Evaluation summary: novopen (tm)echo (tm)rouge - batch (b)(4).Visual and functional examinations were performed.The device was tested with a random cartridge and a novo nordisk needle was mounted.All mechanical functions are normal including the piston rod function.The dose accuracy was measured by weighing using a random cartridge.The results were found to comply with specifications.The electronic register was checked.A batch trend report has been created.Nothing abnormal was found.Confirmed: the memory data in the device revealed that the memory display has shown two lines (- -) after attempted injections during use.The observed problem is caused by the use of a clogged needle on the pen.After the injection to follow the display and pen 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.

Event Description

Case description: since last submission the following has been corrected: usage of device updated to reuse.

• 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: 5320595
• MDR Text Key: 34198322
• Report Number: 9681821-2015-00045
• 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
• Report Date: 11/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/29/2016
• Device Model Number: N/A
• Device Catalogue Number: 185459
• Device Lot Number: DV40240
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2014
• 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): Other
• Patient Age: 8 YR