MAUDE Adverse Event Report: NOVO NORDISK A/S, MEDICAL SYSTEMS NOVOPEN 3; INSULIN DELIVERY DEVICE

Model Number N/A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Hypoglycemia (1912); Overdose (1988); Not Applicable (3189)

Event Date 07/21/2013

Event Type  Injury  

Event Description

Applied 70u beyond his dosage, was almost in coma, treated with intravenous glucose [hypoglycaemic coma].Numbers of novopen 3 where he selects the dosage were rubbed out [device physical property issue].Applied 70u beyond his dosage [accidental overdose].Alteration on his blood glucose [blood glucose abnormal].Hypoglycaemic crisis.Case description: this serious spontaneous case from brazil was reported by a consumer as "applied 70u beyond his dosage, was almost in coma, treated with intravenous glucose" beginning on (b)(6) 2013, "numbers of novopen 3 where he selects the dosage were rubbed out" with an unspecified onset date, "70u beyond his dosage" with an unspecified onset date, "alteration on his blood glucose" with an unspecified onset date, "hypoglycaemic crisis" with an unspecified onset date, and concerned a male patient who was treated with novolin n penfill (insulin human) from unknown start date and ongoing due to "type 2 diabetes mellitus", novopen 3 (insulin delivery device) from unknown start date due to "type 2 diabetes mellitus".Medical history included type 2 diabetes mellitus, did not have a good vision.Concomitant products included - novorapid (insulin aspart) solution for injection, 100 u/ml.Treatment included - glucose(glucose).The patient started using novolin n penfill 25 years before the time of report.The patient used novolin n penfill with a novopen 3 silver.The patient complained that the numbers of the novopen 3 where the dosage was selected were rubbed off why there were not visible.Therefore, the dosage of medication with the use of the pen was unknown.On (b)(6) 2013 the patient applied 70u beyond the dosage, due to lack of vision and due to the missing numbers on the pen.Subsequently, the patient became paralyzed and could not speak.According to the reporter the patient was almost in coma.The patient was hospitalized at emergency room and was treated with intravenous glucose and recovered.On an unknown date the patient had an alteration in the blood glucose level and some hypoglycaemic crisis while using 40u.Because of this the patient's physician divided the dose to 20u at lunch and 20u at night.Recently the patient started using novorapid.Action taken to novolin n penfill was not reported.Action taken to novopen 3 was not reported.The outcome for the event "applied 70u beyond his dosage, was almost in coma, treated with intravenous glucose" was recovered.The outcome for the event "numbers of novopen 3 where he selects the dosage were rubbed out" was not reported.The outcome for the event "70u beyond his dosage" was not reported.The outcome for the event "alteration on his blood glucose" was unknown.The outcome for the event "hypoglycaemic crisis" was unknown.

Event Description

Case description: investigation result: name: novolin n penfill® 5 x penfill 3 ml - 100 ui/ml.No investigation was possible, because neither sample nor batch number was available.Name: novopen 3.No investigation was possible, because neither sample nor batch number was available.Manufacturer comment: on 01-mar-2017: as novopen 3 has not been returned to novo nordisk a/s for investigation and only very limited information regarding the handling of novopen 3 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: novolin n penfill® 5 x penfill 3 ml - 100 ui/ml.No investigation was possible, because neither sample nor batch number was available.Name: novopen 3.No investigation was possible, because neither sample nor batch number was available.

• Brand Name: NOVOPEN 3
• Type of Device: INSULIN DELIVERY DEVICE
• Manufacturer (Section D): NOVO NORDISK A/S, MEDICAL SYSTEMS; hilleroed, 3400 ; DA 3400
• Manufacturer (Section G): NOVO NORDISK A/S, MEDICAL SYSTEMS; brennum park; hilleroed, 3400 ; DA 3400
• Manufacturer Contact: novoprod novo nordisk inc. ; p.o. box 846; plainsboro, NJ 08536 ; 8007276500
• MDR Report Key: 6337121
• MDR Text Key: 67650274
• Report Number: 9681821-2017-00009
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• 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: 01/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 185290
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: NOVORAPID (INSULIN ASPART) SOL FOR INJ 100 U/ML
• Patient Outcome(s): Hospitalization; Other