MAUDE Adverse Event Report: NOVO NORDISK A/S, MEDICAL SYSTEMS NOVOPEN 4; INSULIN DELIVERY DEVICE

Model Number N/A

Device Problems Failure to Deliver (2338); Mechanical Jam (2983)

Patient Problems Electrolyte Imbalance (2196); Loss of consciousness (2418)

Event Date 06/01/2019

Event Type  Injury  

Event Description

Loss of consciousness [loss of consciousness].Health condition deterioration [general physical health deterioration].High blood glucose up to 18 mmol/l [blood glucose increased].Piston rod of the injector didn't move forward [device issue].Breakage of novopen 4 [device breakage].Insulin has not gone out for several days [device failure].Store the injector with attached needle [product storage error].Case description: this serious spontaneous case from (b)(6) was reported by a pharmacist as "loss of consciousness" beginning on (b)(6) 2019, "health condition deterioration" with an unspecified onset date, "piston rod of the injector didn't move forward" beginning on (b)(6) 2019, "insulin has not gone out for several days" beginning on (b)(6) 2019, "high blood glucose up to 18 mmol/l" beginning on (b)(6) 2019, "store the injector with attached needle" with an unspecified onset date, and concerned a (b)(6) female patient who was treated with novopen 4 (insulin delivery device) from (b)(6) 2018 to (b)(6) 2019 due to "type 2 diabetes mellitus".The patient's height, weight and body mass index were not reported.Medical history included type 2 diabetes mellitus since 2017.Concomitant products included - actrapid hm(insulin human) solution for injection, 100 iu/ml 2017 to ongoing.On an unspecified date in (b)(6) 2019, patient presented high blood glucose up to 18 mmol/l with health condition deterioration and loss of consciousness due to technical breakage of novopen 4.It was reported that piston rod of the injector didn't move forward, and insulin has not gone out for several days.It was reported that the patient re-uses needle - one needle for one week / 21 injections and stores the injector with attached needle.The batch number of novopen 4 was available.Action taken to novopen 4 was reported as product discontinued due to ae.On (b)(6) 2019 the outcome for the event "loss of consciousness" was recovered.The outcome for the event "health condition deterioration" was recovered.The outcome for the event "piston rod of the injector didn't move forward" was not reported.The outcome for the event "insulin has not gone out for several days" was not reported.On (b)(6) 2019 the outcome for the event "high blood glucose up to 18 mmol/l" was recovered.The outcome for the event "store the injector with attached needle" was not reported.No further information available.Investigation results: name: novopen 4, batch number: hvgl119-1.The product was not returned for examination.The complaint was registered in the novo nordisk complaint handling system.The batch documentation was reviewed.No abnormalities relating to the observed problem were found.The batch documentation was reviewed.Nothing abnormal was found.Manufacturer comment: on 05-jul-2019: as the device (novopen 4) 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 (b)(4).

• Brand Name: NOVOPEN 4
• Type of Device: INSULIN DELIVERY DEVICE
• Manufacturer (Section D): NOVO NORDISK A/S, MEDICAL SYSTEMS; hilleroed, ; DA
• Manufacturer (Section G): NOVO NORDISK A/S, MEDICAL SYSTEMS; brennum park; hilleroed, 3400, ; DA
• Manufacturer Contact: p.o. box 846; plainsboro, NJ 08536 ; 8007276500
• MDR Report Key: 8776072
• MDR Text Key: 150574249
• Report Number: 9681821-2019-00042
• 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: foreign,health professional
• Type of Report: Initial
• Report Date: 06/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/01/2023
• Device Model Number: N/A
• Device Catalogue Number: 185490
• Device Lot Number: HVGL119-1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2018
• 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: ACTRAPID HM (INSULIN HUMAN)
• Patient Outcome(s): Other
• Patient Age: 64 YR