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

Model Number N/A

Device Problems Use of Device Problem (1670); Malposition of Device (2616)

Patient Problems Blurred Vision (2137); Dizziness (2194); Coma (2417); Sweating (2444); Shaking/Tremors (2515)

Event Date 05/03/2015

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas) coma [coma] the patient opened the pen on the cartridge while it was used.Hence the piston rod screwed down and was not touching the end of the cartridge resulting no insulin released [device use error] case description: this serious spontaneous case from egypt was reported by a consumer as "coma" beginning on (b)(6) 2015 and "the patient opened the pen on the cartridge while it was used.Hence the piston rod screwed down and was not touching the end of the cartridge resulting no insulin released " with an unspecified onset date, and concerned a (b)(6) male patient who was treated with mixtard 30 hm penfill (dual acting human insulin) from (b)(6) 2015 to (b)(6) 2015 for an unknown indication and novopen 4 (insulin delivery device) from unknown start date as "device therapy" patient's weight: (b)(6) patient's height and bmi were not reported.Medical history was not provided.Concomitant products included - glucophage (metformin hydrochloride), zantac (ranitidine hydrochloride), napizole (omeprazole) and non-codable concomitant medication includes masapucle from (b)(6) 2015.On (b)(6) 2015, the patient entered in a coma and was hospitalised on (b)(6) 2015 and got discharged on same day at night.The patient was dizzy and had blurry vision, sweat with no effort and shaking.The patient was treated by a physician.The patient went to novocare centre with the cartridge inside the novopen 4 and it was discovered that the patient opened the pen on the cartridge while it was used.Hence the piston rod screwed down and was not touching the end of the cartridge.As a result, when the patient was injecting the dose, no insulin was released during dose injection.Action taken to mixtard 30 hm penfill and novopen 4 was not reported.The outcome for the event "coma" was recovered on an unknown date.The outcome for the event "piston rod screwed down and was not touching the end of the cartridge (no insulin was released during dose injection)" was not reported.

Event Description

Case description: no further information was available at the time of reporting.Investigation results: mixtard 30 penfill 3 ml 100iu/ml; batch number: dr7b467; a batch trend report was created.Nothing abnormal was found.The product was not returned for examination.Novopen 4; batch number: evg2665-1.A batch trend report was created.Nothing abnormal was found.The product was not returned for examination.Since last submission, the case has been updated with the following: investigational results updated; manufacturer comment added; narrative and relevant fields updated accordingly.Final manufacturer comment: 14-jul-2015: a gap between the plunger and the piston rod washer can occur when the user is leaving the needle attached to the pen in between injections or inserting a partly used cartridge in the cartridge holder and neglecting to check the insulin flow before injecting the dialled dose.Both scenarios are in contradiction with the user manual of the pen.When there is a gap, no insulin or less insulin was coming out.In this case, it is not reported what is the exact cause of the coma.As novopen 4 has not been returned to novo nordisk a/s for investigation and only limited information regarding the handling of suspected device and the course of the event 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).Evaluation summary: mixtard 30 penfill 3 ml 100iu/ml, batch number: dr7b467.A batch trend report was created.Nothing abnormal was found.The product was not returned for examination.Novopen 4, batch number: evg2665-1.A batch trend report was created.Nothing abnormal was found.The product was not returned for examination.

• Brand Name: NOVOPEN 4
• Type of Device: INSULIN DELIVERY DEVICE
• Manufacturer (Section D): NOVO NORDISK A/S; bagsvaerd, ; DA
• Manufacturer (Section G): NOVO NORDISK A/S, MEDICAL SYSTEMS; brennum park; hileroed, 3400 ; DA 3400
• Manufacturer Contact: p.o. box 846; plainsboro, NJ 08536
• MDR Report Key: 4865466
• MDR Text Key: 5811623
• Report Number: 9681821-2015-00020
• 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,Consumer,consumer,foreign
• Type of Report: Initial
• Report Date: 06/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 185490
• Device Lot Number: EVG2665-1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2015
• 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: ZANTAC (RANITIDINE HYDROCHLORIDE); NAPIZOLE/00661201/ (OMEPRAZOLE)
• Patient Outcome(s): Hospitalization
• Patient Age: 60 YR
• Patient Weight: 55