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

Model Number N/A

Device Problems Defective Component (2292); Inaccurate Delivery (2339)

Patient Problems Hyperglycemia (1905); Coma (2417)

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas).Diabetic coma [diabetic coma].Piston rod problem in his novopen 4 [device issue].Case description: this serious spontaneous case from egypt was reported by a consumer as "diabetic coma(diabetic coma)" with an unspecified onset date, "piston rod problem in his novopen 4(device component issue)" with an unspecified onset date, and concerned a patient (age and gender not reported) who was treated with novopen 4 (insulin delivery device) from unknown start date for "diabetes mellitus", , actrapid penfill (insulin human) solution for injection, 100 iu/ml (dose, frequency & route used - 35 iu, qd (6-8-11), unknown) (actrapid penfill regimen #2 - dose, frequency & route used - dose increased, unknown, therapy dates - ongoing) from unknown start date and ongoing for "diabetes mellitus".The patient's height, weight and body mass index were not reported.Current condition: diabetes mellitus (type and duration: not reported).Concomitant products included - lantus(insulin glargine) it was reported that there was a piston rod problem in his novopen 4 and the patient suffered from diabetic coma and was hospitalized.On (b)(6) 2021 random blood sugar (rbs) was 75mg/dl and one hour later after having glucose source rbs reached to 85 mg/dl then increased gradually to be 130 mg/dl after having the meal.It was reported that parent was the operator of the device at the time of the event and sometimes the patient.The parents have been trained by a health care professional in the use of the novopen.Also it was reported that the patient already in general reuse the needles for 3 days and keep the needle attached to the pen in between injections.Batch numbers: novopen 4: unknown; actrapid penfill: asku, asku.Action taken to novopen 4 was not reported.Action taken to actrapid penfill was reported as dose increased.The outcome for the event "diabetic coma(diabetic coma)" was not reported.The outcome for the event "piston rod problem in his novopen 4(device component issue)" was not reported.References included: reference type: e2b company number, reference id#: eg-novoprod-806327 reference notes:, 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.Preliminary manufacturer's comment: 26-apr-2021: the suspected device has not been returned to novo nordisk for investigation.No conclusion is reached.

Event Description

Case description: investigation result: name: novopen 4 - batch unknown.No investigation was possible, because neither sample nor batch number was available.Name: actrapid penfill 3 ml 100iu/ml - batch unknown.No investigation was possible, because neither sample nor batch number was available.Since last submission, the following has been update in the case: -investigation result updated as "no investigation was possible, because neither sample nor batch number was available." -manufacturers comment updated.-narrative was updated accordingly.Final manufacturer's comment: 25-jun-2021: the suspected device (novopen 4) has not been returned to novo nordisk for the investigation.Batch number of device is not available, no batch trend analysis performed.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, needle re-use and leaving the needle attached to device between injections are significant confounding factors which could have led to device malfunction and hyperglycaemia and its complication.Reported events are listed.This single case report is not considered to change the current knowledge of the safety profile actrapid penfill.H3 continued: evaluation summary: investigation result: name: novopen 4 - batch unknown.No investigation was possible, because neither sample nor batch number was available.

• Brand Name: NOVOPEN 4
• Type of Device: INSULIN DELIVERY DEVICE
• Manufacturer (Section D): NOVO NORDISK A/S, MEDICAL SYSTEMS; hilleroed, ; DA
• MDR Report Key: 11821291
• MDR Text Key: 265201663
• Report Number: 9681821-2021-00020
• 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
• Type of Report: Initial,Followup
• Report Date: 04/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• 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
• Date Manufacturer Received: 06/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LANTUS (INSULIN GLARGINE)
• Patient Outcome(s): Hospitalization