MAUDE Adverse Event Report: NOVO NORDISK A/S NOVOPEN 3 DEMI INSULIN DELIVERY DEVICE

Model Number N/A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Hyperglycemia (1905); No Code Available (3191)

Event Date 01/01/2017

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas) diabetes mellitus type 1 in decompensation stage (high blood glucose level up to 26 mmol/l) [blood glucose increased], insulin is leaking when using the injector [device leakage], lack of novorapid efficacy [drug ineffective]. Case description: this serious spontaneous case from russian federation was reported by a consumer as "diabetes mellitus type 1 in decompensation stage (high blood glucose level up to 26 mmol/l)" beginning on (b)(6) 2017, "insulin is leaking when using the injector" beginning on (b)(6) 2017 and "lack of novorapid efficacy" beginning on (b)(6) 2017, and concerned a (b)(6) year-old female patient who was treated with novopen 3 demi (insulin delivery device) from 2008 and ongoing due to "type 1 diabetes mellitus" and novorapid penfill (insulin as part) from 2008 and ongoing due to "type 1 diabetes mellitus". A non-novo nordisk suspected product includes lantus (insulin glargine) from 2011 to (b)(6) 2017 due to "type 1 diabetes mellitus". Patient's body mass index (bmi): 19. 5. Concomitant medication: tresiba flextouch u100 (insulin degludec) solution for injection, 100 u/ml from (b)(6) 2017 and ongoing due to "type 1 diabetes mellitus". Since (b)(6) 2017, patient's blood glucose level reported to be high. In (b)(6) 2017, leaking of insulin was seen when using the injector. On (b)(6) 2017, the patient was hospitalized due to high blood glucose level up to 26 mmol/l. It was diagnosed as diabetes mellitus type 1 in decompensation stage without ketose. It was reported that the patient had diabetic peripheral sensorimotor polyneuropathy on an unknown date. On (b)(6) 2017, patient was discharged from hospital. On (b)(6) 2017 the outcome for the event "diabetes mellitus type 1 in decompensation stage (high blood glucose level up to 26 mmol/l)" was recovered. On (b)(6) 2017 the outcome for the event "lack of novorapid efficacy" was recovered. Investigation result: novopen 3 demi, batch number: rv40250. The product was not returned for examination. The complaint has been registered in the novo nordisk complaint handling system. Since last submission, the following was updated: discharge date updated. Novopen 3 demi batch number added. Outcome for the event "novorapid efficacy" was reported as recovered. Investigation result updated. Manufacturer's comment updated. Narrative updated accordingly. Manufacturers comment: (b)(6) 2017: as the device (novopen 3 demi) 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 argus case 548678. The reported aes are assessed as listed according to the nn current reference safety information on novorapid. This single case report is not considered to change the current knowledge of the safety profile of novorapid. Suspect products: #1 novorapid penfill (insulin aspart) solution for injection, 100u/ml, regimen #1 29 u, qd (29 units per day: 09 - 10 - 10), subcutaneous, regimen #2 30-35 units per day, subcutaneous, therapy dates: --/--/2008 to ongoing, lot # fj30042. #2 lantus (insulin glargine), regimen #1 27 u, qd, subcutaneous, therapy dates: --/--/2011 to (b)(6) 2017, lot # unknown. Evaluation summary: name: novorapid® penfill® 100 u/ml, batch number: fj30042 inv-0334856: the product was not returned for examination. If possible, please forward the reported product(s) for further investigations. The complaint has been registered in the novo nordisk complaint handling system. Name: tresiba® flextouch® 100 u/ml, batch number: fp53104 inv-0334855: the product was not returned for examination. If possible, please forward the reported product(s) for further investigations. The complaint has been registered in the novo nordisk complaint handling system. Name: novopen® 3 demi, batch number: rv40250 inv-0334852: the product was not returned for examination. If possible, please forward the reported product(s) for further investigations. The complaint has been registered in the novo nordisk complaint handling system. Name: lantus, batch number: unknown. Non-novo nordisk product or concomitant product or safety only case category.

Event Description

High blood glucose level up to 26 mmol/l. [blood glucose increased]. Insulin is leaking when using the injector [device leakage]. Lack of novorapid efficacy [drug ineffective]. Case description: this serious spontaneous case from russian federation was reported by a consumer as "high blood glucose level up to 26 mmol/l. " beginning on (b)(6) 2017, "insulin is leaking when using the injector" with an unspecified onset date, "lack of novorapid efficacy" beginning on (b)(6) 2017, and concerned a (b)(6) female patient who was treated with novopen 3 demi (insulin delivery device) from 2008 and ongoing due to "type 1 diabetes mellitus", novorapid penfill (insulin aspart) from 2008 and ongoing due to "type 1 diabetes mellitus". A non-novo nordisk suspect product includes lantus (insulin glargine) from 2011 to (b)(6) 2017 due to "type 1 diabetes mellitus". Concomitant medication: tresiba flextouch u100 (insulin degludec) solution for injection, 100 u/ml from (b)(6) 2017 and ongoing due to "type 1 diabetes mellitus". (b)(6). Medical history includes type 1 diabetes mellitus since 2008 and myopia. The reporter complained about novopen 3 demi. The injector has been used for about 9 years and insulin is leaking when using the injector. On (b)(6) 2017, patient was hospitalized due to high blood glucose level up to 26 mmol/l. On (b)(6) 2017, patient was switched from lantus to tresiba in the hospital. Her blood glucose decreased from 26 to 10 - 15 mmol/l, but had not reached the patient's blood glucose target value (at the time of report). In the reporter's opinion there was lack of novorapid efficacy. Action taken to novopen 3 demi was reported as no change. Action taken to novorapid penfill was reported as no change. Action taken to lantus was reported as product discontinued. The outcome for the event "high blood glucose level up to 26 mmol/l. " was not yet recovered. The outcome for the event "insulin is leaking when using the injector" was not reported. The outcome for the event "lack of novorapid efficacy" was not yet recovered.

• Brand Name: NOVOPEN 3 DEMI
• Type of Device: INSULIN DELIVERY DEVICE
• Manufacturer (Section D): NOVO NORDISK A/S; krogshoejvej 55; bagsvaerd, ; DA
• Manufacturer (Section G): NOVO NORDISK A/S, MEDICAL SYSTEMS; brennum park; hilleroed, 3400 ; DA 3400
• Manufacturer Contact: novo nordisk inc.; p.o. box 846; plainsboro 08536
• MDR Report Key: 6646125
• MDR Text Key: 200588585
• Report Number: 9681821-2017-00026
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• PMA/PMN Number: 19-938
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 06/01/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 10/16/2015
• Device Model Number: N/A
• Device Catalogue Number: 185258
• Device Lot Number: RV40250
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 06/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 06/16/2017 Patient Sequence Number: 1

Treatment

TRESIBA FLEXTOUCH U100 (INSULIN DEGLUDEC)