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

Model Number N/A

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem Hypoglycemia (1912)

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas).Hypoglycemia [hypoglycaemia].The pen is not working properly, and it releases more insulin than the required dose [device malfunction].The pen is not working properly, and it releases more insulin than the required dose [incorrect dose administered by device].Case description: study id: (b)(6) 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 height, weight and body mass index: not reported.This serious solicited report from egypt was reported by a consumer as "hypoglycaemia" with an unspecified onset date , "the pen is not working properly, and it releases more insulin than the required dose" with an unspecified onset date , "the pen is not working properly, and it releases more insulin than the required dose" with an unspecified onset date and concerned a female patient who was treated with novopen 4 (insulin delivery device) from unknown start date due to "diabetes mellitus", , actrapid penfill hm(ge) (insulin human) from unknown start date due to "diabetes mellitus" (dose and frequency unknown).Medical history included diabetes mellitus (type and duration unknown).Concomitant medications included - lantus solostar (insulin glargine) solution for injection, 100 u/ml.On an unknown date, the pen was not working properly, and it released more insulin than the required dose.That had caused severe hypoglycaemia, and the patient had to be hospitalized more than 5 times a month.Their hcp said that the pen caused the hypoglycemia.When actrapid vial was given by a syringe, the blood glucose level was adjusted.The hcp was contacted and denied that the pen had caused the hypoglycemia.Batch number of novopen and actrapid has been requested.Action taken to novopen 4 is not reported.Action taken to actrapid penfill hm(ge) was not reported.The outcome for the event "hypoglycemia" was recovered.The outcome for the event "the pen is not working properly, and it releases more insulin than the required dose" was recovered.The outcome for the event "the pen is not working properly, and it releases more insulin than the required dose" was recovered.Reporter's causality ( novopen 4) - hypoglycemia : probable.The pen is not working properly, and it releases more insulin than the required dose : unknown.The pen is not working properly, and it releases more insulin than the required dose : unknown.Company's causality ( novopen 4) - hypoglycemia : possible.The pen is not working properly, and it releases more insulin than the required dose : possible.The pen is not working properly, and it releases more insulin than the required dose : possible.Reporter's causality ( actrapid penfill hm(ge)) - hypoglycemia : unlikely.The pen is not working properly, and it releases more insulin than the required dose : unknown.The pen is not working properly, and it releases more insulin than the required dose : unknown.Company's causality ( actrapid penfill hm(ge)) - hypoglycemia : possible.The pen is not working properly, and it releases more insulin than the required dose : unlikely.The pen is not working properly, and it releases more insulin than the required dose : unlikely.Reporter comment: causality as reported: for novopen 4 is probable, for actrapid penfill is unlikely.

Event Description

Case description: the outcome for the event "the pen is not working properly, and it releases more insulin than the required dose" was not reported.The outcome for the event "the pen is not working properly, and it releases more insulin than the required dose" was not reported.Investigation result: novopen 4: batch unknown.The product was not returned for examination.The complaint had been registered in the novo nordisk complaint handling system.The batch documentation was reviewed no abnormalities relating to the observed problem were found.Nothing abnormal was found.Actrapid penfill: no investigation was possible, because neither sample nor batch number was available.Since last submission the case updated with the following information: outcome for the event "the pen is not working properly, and it releases more insulin than the required dose" updated.Investigation report updated.Manufacturer's comment updated.Narrative updated accordingly.Manufacturer's comment: 20-feb-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).The reported events are listed.This single case report is not considered to change the current knowledge of the safety profile of actrapid penfill.Device evaluated by mfr: continued: evaluation summary: inv-0462475: the product was not returned for examination.The complaint has been registered in the novo nordisk complaint handling system.The batch documentation was reviewed no abnormalities relating to the observed problem were found.Nothing abnormal was 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: 8348363
• MDR Text Key: 136602472
• Report Number: 9681821-2019-00010
• 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: 01/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 185490
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/23/2019
• Initial Date FDA Received: 02/18/2019
• Supplement Dates Manufacturer Received: 02/18/2019
• Supplement Dates FDA Received: 03/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 1) LANTUS SOLOSTAR (INSULIN GLARGINE)
• Patient Outcome(s): Hospitalization