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 Hyperglycemia (1905); Coma (2417)

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas) novopen4 didn't push insulin [device failure] coma [coma] more difficult force needed to inject novopen4 [device difficult to use] case description: study id: (b)(4) 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.The patient's height, weight and body mass index were not reported.This serious solicited report from (b)(6) was reported by a consumer as "novopen4 didn't push insulin(device failure)" with an unspecified onset date , "coma(coma)" with an unspecified onset date , "more difficult force needed to inject novopen4(device difficult to use)" with an unspecified onset date and concerned a female patient who was treated with mixtard 30 hm penfill (insulin human) suspension for injection, 100 iu/ml (dose, frequency & route used - 35 iu, qd (20+15), unknown) (therapy dates - ongoing) from unknown start date and ongoing for "diabetes mellitus", novopen 4 (insulin delivery device) from unknown start date for "diabetes mellitus", dosage regimens: mixtard 30 hm penfill: novopen 4: current condition: diabetes mellitus(type and duration not reported).The patient started using novopen 4 and mixtard 30 penfills from 4 or 5 years.On an unknown date, novopen4 didn't push insulin for one month and the patient didn't know that she wasn't taking insulin which led to coma.Coma lasted for a day but patient didn't get hospitalized.It was reported that the patient had blood sugar level 250 mg/dl rbs and hadn't any episodes of hyperglycemia due to the technical issue.The patient haven't changed his diet or exercise level.The patient was trained by a health care professional in the use of the novopen.The patient already in general reuse the needles(unspecified needle).The needle left attached to the pen in between injections.It was reported that the force needed to inject feel different from normal and was more difficult.The patient switched to use another novopen 4 one week ago.Batch number of novopen 4 was hvgn733 and mixtard 30 hm penfill has been requested.Action taken to mixtard 30 hm penfill was not reported.Action taken to novopen 4 was not reported.The outcome for the event "novopen4 didn't push insulin(device failure)" was recovered.The outcome for the event "coma(coma)" was recovered.The outcome for the event "more difficult force needed to inject novopen4(device difficult to use)" was recovered.Reporter's causality (mixtard 30 hm penfill) - novopen4 didn't push insulin(device failure) : unlikely coma(coma) : unlikely more difficult force needed to inject novopen4(device difficult to use) : unlikely company's causality (mixtard 30 hm penfill) - novopen4 didn't push insulin(device failure) : possible coma(coma) : unlikely more difficult force needed to inject novopen4(device difficult to use) : possible reporter's causality (novopen 4) - novopen4 didn't push insulin(device failure) : probable coma(coma) : probable more difficult force needed to inject novopen4(device difficult to use) : probable company's causality (novopen 4) - novopen4 didn't push insulin(device failure) : possible coma(coma) : unlikely more difficult force needed to inject novopen4(device difficult to use) : possible in order to protect the safety of patient it will, in rare cases, be required to disassemble the medical device immediately in a way where it is not subsequently possible to reassemble it (e.G.Destructive testing or altering of the medical device).The disassembled medical device will be stored with the same retention period as other complaint samples.References included: reference type: e2b company number reference id#: (b)(4).Reference notes: preliminary manufacturer's comment: on (b)(6) 2021: the suspected device novopen 4 has not been returned to novo nordisk for evaluation.No conclusion is reached.Product handling error such as needle re-use and leaving the needle attached to device between injections are significant risk factors which could have led to device malfunction and hyperglycaemia and its complication.Company comment: coma is assessed as unlisted according to the novo nordisk current ccds in novomix 30 penfill.Relevant information on medical history, type and duration of diabetes mellitus, any history of infection, trauma, diet change, final diagnosis, treatment given, action taken with suspected products and investigation of the suspected product (device and novomix 30 penfill) are unavailable for complete causality assessment.This single case report is not considered to change the current knowledge of the safety profile of novomix 30 penfill.

Event Description

Case description: investigation result: name: novopen 4 - batch hvgn733.The product was not returned for examination.The batch documentation has been reviewed and found to be normal.No abnormalities relating to the observed problem were found.Name: mixtard 30 penfill 3 ml 100iu/ml - batch unknown.No investigation was possible, because neither sample nor batch number was available.Since last submission the case has been updated with the following information:-investigation result updated, manufacturer's comment updated, narrative updated accordingly.References included: reference type: e2b company number, reference id#: (b)(4), reference notes:.Final manufacturer's comment: 02-jul-2021: the suspected device (novopen 4) has not been returned to novo nordisk a/s for the investigation.The batch trend analysis and reference sample examination revealed nothing abnormal.No abnormalities relating to the observed problem were found.With the available limited information regarding the handling of the suspected device, it is not possible to identify a clear root cause in relation to functionality of novopen 4.However, product handling error such as needle re-use and leaving the needle attached to device between injections are significant risk factors which could have led to device malfunction and hyperglycaemia and its complication.H3 continued: evaluation summary investigation result: novopen 4 - batch hvgn733 the product was not returned for examination.The batch documentation has been reviewed and found to be normal.No abnormalities relating to the observed problem were found.

• Brand Name: NOVOPEN 4
• Type of Device: INSULIN DELIVERY DEVICE
• Manufacturer (Section D): NOVO NORDISK A/S, MEDICAL SYSTEMS; hilleroed, ; DA
• MDR Report Key: 11827029
• MDR Text Key: 258875066
• Report Number: 9681821-2021-00021
• 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: 04/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/17/2023
• Device Model Number: N/A
• Device Catalogue Number: 185490
• Device Lot Number: HVGN733
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other