MAUDE Adverse Event Report: NOVO NORDISK A/S NOVOPEN 4; INSULIN DELIVEY DEVICE

Model Number N/A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Not Applicable (3189); No Code Available (3191)

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas) unable to control glucose [diabetes mellitus inadequate control] novopen 4 causes air bubbles [device issue] air bubble inside novolin n penfill [liquid product physical issue] lack of efficacy [drug ineffective] case description: this serious spontaneous case from (b)(6) was reported by a consumer as "unable to control glucose", "novopen 4 causes air bubbles", "lack of efficacy" and "air bubble inside novolin n penfill" all with an unspecified onset date, and concerned a female patient (age not reported) who was treated with suspect drug, novolin n penfill (long acting human insulin) from unknown start date (since 10 years) and ongoing for unknown indication and used suspect device, novopen 4 (insulin delivery device) from an unknown date in 2015 as device therapy.Patient's height, weight and body mass index were not reported.Medical history include patient has 3 stents since 2013 (02 years) and fat plaques in the arteries.It was reported that the patient had stents since (b)(6) 2013.In this period, the patient was using novopen 3 (lv40187) with novolin n penfill.Concomitant product included novofine 6 mm(needle)0 the patient was using novopen 4 with novolin n penfill.Novolin n was used in the morning and on an unknown date, the glycaemia increased to 200mg/dl at night.The patient had 03 stents because of fat plaques in the arteries and needed to keep a very low level of glucose, being well controlled.Novolin n has been used for 10 years and the patient had stents for 2 years.However, with novolin n and novopen 4, the patient was unable to control glucose and remove the air bubbles.It was reported that the patient's novolin n penfill (batch (b)(4)) had air bubble inside it.Flow verification test was performed 06 times in order to remove the air without success.The patient reported lack of efficacy.The patient was using 4iu, but as it was not making effect, the dose was increased to 8iu, performing 2 applications per day.The insulin was not making effect and glycaemia reached 250 mg/dl.The patient also had another pen (similar to novopen 4) which was used with novolin n and there was no air bubble.Novopen 4 (batch (b)(4)) was used for about a month.The patient believed that novopen 4 caused air bubbles and changes to the penfill.Novofine 6mm is used by disposable way.Action taken to novolin n penfill was not reported.The outcome for the event "unable to control glucose" was not recovered.The outcome for the event "novopen 4 causes air bubbles" was not reported.The outcome for the event "air bubble inside novolin n penfill" was not reported.The outcome for the event "lack of efficacy" was not recovered.

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas) case description: the patient was also feeling weakness and headache.The patient had started using novolin r penfill batch number: (b)(4) a week prior to receipt of follow up.Upon follow up it was reported that the patient performed more or less 4 injections.Small bubbles would appear which would develop into a big bubble.The product was transported correctly and bought at the drugstore.The product in use was stored out of refrigerator.Action taken to novolin n penfill and novopen 4 was not reported.The outcome for the event "unable to control glucose" was not recovered.The outcome for the event "novopen 4 causes air bubbles" was not reported.The outcome for the event "air bubble inside novolin n penfill" was not reported.The outcome for the event "lack of efficacy" was not reported.Investigation result: novolin n penfill 5 x penfill 3 ml - 100 ui/ml; batch: (b)(4).A batch trend report was created.Nothing abnormal was found.The product was not returned for examination.Name:novopen 4; batch number: (b)(4).A batch trend report was created.Nothing abnormal was found.The product was not returned for examination.The batch documentation was reviewed.No abnormalities relating to the observed problem were found.Non-conformity-related documentation was examined.No irregularities recorded therefore no further action was taken.Since last submission the case has been updated with the following: -investigation results added -additional device problem code added -final manufacturer comment added -narrative and tabs updated accordingly final manufacturer comment: 22-dec-2015: as device novopen 4 has not been received by 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 (b)(4).Continued: evaluation summary: name: novopen 4, batch number: (b)(4).A batch trend report was created.Nothing abnormal was found.The product was not returned for examination.The batch documentation was reviewed.No abnormalities relating to the observed problem were found.Non-conformity-related documentation was examined.No irregularities recorded therefore no further action was taken.

• Brand Name: NOVOPEN 4
• Type of Device: INSULIN DELIVEY DEVICE
• Manufacturer (Section D): NOVO NORDISK A/S; bagsvaerd, ; DA
• Manufacturer (Section G): NOVO NORDISK A/S, MEDICAL SYSTEMS; hilleroed, 3400 ; DA 3400
• Manufacturer Contact: novoprod novo nordisk inc. ; p.o. box 846; plainsboro, NJ 08536 ; 8007276500
• MDR Report Key: 5271047
• MDR Text Key: 32808508
• Report Number: 9681821-2015-00037
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: 20-986
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 11/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/07/2018
• Device Model Number: N/A
• Device Catalogue Number: 185490
• Device Lot Number: CUG0199
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2013
• 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