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); No Flow (2991)

Patient Problems Hyperglycemia (1905); Coma (2417)

Event Date 09/02/2018

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas).It did not inject insulin [device failure].Diabetic coma [diabetic coma].Case description: study id: (b)(6) novocare programme.Study description: trial title: main objective of the programme is to help patients to understand their diabetes and maintain normal life through qualified educators who offer simple and practical information directly to the patients and also, train patients on how to use their insulin devices and needles etc.Patient's weight: (b)(6).Patient's height and bmi was not reported.This serious solicited report from egypt was reported by a consumer as "it did not inject insulin" with an unspecified onset date , "diabetic coma" beginning on (b)(6) 2018 and concerned a (b)(6) old female patient who was treated with, mixtard 30 penfill hm(ge) (insulin human) from unknown start date due to "type 1 diabetes mellitus" (dose and frequency 20 u morning , 10 u night), novopen 4 (insulin delivery device) from unknown start date due to "type 1 diabetes mellitus".Medical history included diabetes mellitus type 1, cerebral palsy, epilepsy.Concomitant medications included - tiratam(levetiracetam) ongoing, novorapid penfill(insulin aspart) solution for injection, 100 u/ml.On an unknown date, the patient started treatment with mixtard 30 penfill and novopen 4.On an unknown date the insulin was not injected and on (b)(6) 2018 the patient experienced diabetic coma.The patient was hospitalised due to diabetic coma from (b)(6) 2018 to (b)(6) 2018.It was reported the patient was hospitalised in the intensive care unit for 5 days as her pen was not injecting insulin for 3 days , on the first day, the patient's temperature was high and she was very sleepy then in the third day, she suffered from diabetic coma and her blood glucose reached 700 mg/dl , they found that her blood gases was high in addition to the acetone.It was reported the patient used novorapid penfill, it's dose was 6 iu at lunch but it was not available in the medical insurance from a long time, so she did not use it at the last period of time (diabetic coma didn't happen during using novorapid penfills).Action taken to novopen 4 was not reported.Action taken to mixtard 30 penfill hm(ge) was not reported.The outcome for the event "it did not inject insulin" was not reported.On (b)(6) 2018 the outcome for the event "diabetic coma" was recovered.Reporter's causality (mixtard 30 penfill hm(ge)) - it did not inject insulin : unknown.Diabetic coma : unlikely.Company's causality ( mixtard 30 penfill hm(ge)) - it did not inject insulin : possible.Diabetic coma : unlikely.Reporter's causality ( novopen 4) - it did not inject insulin : unknown.Diabetic coma : unlikely.Company's causality ( novopen 4) - it did not inject insulin : possible.Diabetic coma : possible.Company comment : the reported events are assessed as listed according to the novo nordisk current reference safety information on mixtard 30.This single case report is not considered to change the current knowledge of the safety profile of mixtard 30.

Event Description

Case description: batch number was available.Investigational results: product name: mixtard 30 hm penfill.Batch number: gr78014.The product was not returned for examination.The complaint has been registered in the novo nordisk complaint handling system.Product name: novopen 4.Batch number:evg2785-1.The batch documentation was reviewed.No abnormalities relating to the observed problem were found.The product was not returned for examination.The complaint has been registered in the novo nordisk complaint handling system.Since last submission, case was updated with the following: the investigation results were updated.The manufacturer's comment was updated.Narrative updated accordingly.On (b)(6) 2018, it was discovered during review of follow-up that this case did not require expedited reporting as the unlisted event of diabetic coma was considered unlikely related by nn.The case is being re-submitted to notify you of the change in status.Manufacturer's comment/company comment : on 02-nov- 2018: as the device novopen 4 has not been returned to novo nordisk a/s for investigation and very limited information regarding the handling of the 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).The reported events are assessed as listed according to the novo nordisk current reference safety information on mixtard 30.This single case report is not considered to change the current knowledge of the safety profile of mixtard 30.H3 continued: evaluation summary: product name: novopen 4.Batch number:evg2785-1.The batch documentation was reviewed.No abnormalities relating to the observed problem were found.The batch documentation has been reviewed.Nothing abnormal was found.The product was not returned for examination.The complaint has been registered in the novo nordisk complaint handling system.

• Brand Name: NOVOPEN 4
• Type of Device: INSULIN DELIVERY DEVICE
• Manufacturer (Section D): NOVO NORDISK A/S, MEDICAL SYSTEMS; hilleroed, ; DA
• MDR Report Key: 7938755
• MDR Text Key: 123074511
• Report Number: 9681821-2018-00062
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• PMA/PMN Number: 20-986
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,study
• Type of Report: Initial,Followup
• Report Date: 09/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2018
• 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: EVG2785-1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NOVORAPID PENFILL (INSULIN ASPART); TIRATAM (LEVETIRACETAM) ONGOING
• Patient Outcome(s): Hospitalization
• Patient Age: 120 MO
• Patient Weight: 29