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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 01/01/2019

Event Type  malfunction  

Event Description

Acetonuria ketonuria, novopen 4 spoiled mixtard 30 penfills device malfunction, novopen 4 spoiled mixtard 30 penfills by formation of aggregates, drug-device interaction.Formation of aggregates different from the normal turbidity of the mixtard 30 liquid product physical issue.Case description: this serious spontaneous case from (b)(6) was reported by a consumer as "acetonuria(acetonuria)" beginning on an unspecified date of 2019, "novopen 4 spoiled mixtard 30 penfills(device malfunction)" beginning on an unspecified date of 2019, "novopen 4 spoiled mixtard 30 penfills by formation of aggregates(drug-device interaction)" beginning on an unspecified date of 2019, "formation of aggregates different from the normal turbidity of the mixtard 30(liquid product physical issue)" beginning on an unspecified date of 2019, and concerned a (b)(6) year-old female patient who was treated with novopen 4 (insulin delivery device) from unknown start date for "type 1 diabetes mellitus", mixtard 30 hm penfill (insulin human) from unknown start date and ongoing for "type 1 diabetes mellitus" (dose and frequency 20 iu, bid (morning and night) ), and actrapid penfill (insulin human) from unknown start date and ongoing for "type 1 diabetes mellitus" (dose and frequency 10 iu, tid (with each meal) ).Patient's height: 165 cm.Patient's weight (was reported in range 63-65 kg) and body mass index (bmi) was not reported.Current condition: type 1 diabetes mellitus (since 21 years ago) , hypertension (since 4 months ago).It was reported that novopen 4 spoiled patient's mixtard 30 penfills by formation of aggregates different from the normal turbidity of the mixtard 30 during (b)(6) 2019 which caused the patient to be hospitalized for 4 days due to acetonuria and during hospitalization, patient stopped injecting insulin with the novopen 4.The patient could not confirm the blood glucose level at that event.The patient's causality is probable regarding to the novopen 4 used with the mixtard 30 penfills with batch number (gvgh078) while unlikely regarding the other pen & insulins.Batch numbers: novopen 4: gvgh078, mixtard 30 hm penfill: asku, actrapid penfill: asku.Action taken to novopen 4 was product discontinued due to adverse event (ae).Action taken to mixtard 30 hm penfill was not reported.Action taken to actrapid penfill was not reported.The outcome for the event "acetonuria(acetonuria)" was recovered.The outcome for the event "novopen 4 spoiled mixtard 30 penfills(device malfunction)" was not reported.The outcome for the event "novopen 4 spoiled mixtard 30 penfills by formation of aggregates(drug-device interaction)" was not reported.The outcome for the event "formation of aggregates different from the normal turbidity of the mixtard 30(liquid product physical issue)" was not reported.Investigation results: product name: actrapid® penfill® 3 ml 100iu/ml, batch: unknown, no investigation was possible, because neither sample nor batch number was available.Product name: mixtard® 30 penfill® 3 ml 100iu/ml, batch: unknown, no investigation was possible, because neither sample nor batch number was available.Product name: novopen® 4, batch: gvgh078, the product was not returned for examination.No investigation was possible, because neither sample nor batch number was available.Manufacturer final comment: on 24-jul-2020: the suspected device (novopen 4) has not been returned to novo nordisk for evaluation.The reference sample was found to be normal.Batch documentation has been reviewed and found to be normal.With limited information regarding the handling of suspected device, it is not possible to identify a clear root-cause of the experienced adverse event.Patient's underlying medical condition of type 1 diabetes mellitus is a significant factor for the development of acetonuria.Company comment: ketonuria and drug - device interaction are assessed as unlisted, liquid product physical issue is assessed as listed according to the nov nordisk current ccds in mixtard 30 hm penfill.The reported events are assessed as unlisted for actrapid penfill as the events occurred with mixtard 30 hm penfill.The suspected device (novopen 4) has not been returned to novo nordisk for evaluation.The reference sample was found to be normal.Batch documentation has been reviewed and found to be normal.With limited information regarding the handling of suspected device, it is not possible to identify a clear root-cause of the experienced adverse event.Patient's underlying medical condition of type 1 diabetes mellitus is a significant factor for the development of acetonuria.This single case report is not considered to change the current knowledge of the safety profile of mixtard 30 hm penfill and actrapid penfill.Reporter comment: -her weight (b)(6) kg.Evaluation summary: investigation results, product name: novopen® 4, batch: gvgh078, the product was not returned for examination.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
• Manufacturer (Section G): NOVO NORDISK A/S, MEDICAL SYSTEMS; brennum park; hilleroed, 3400, ; DA
• Manufacturer Contact: p.o. box 846; plainsboro, NJ 08536 ; 8007276500
• MDR Report Key: 10363672
• MDR Text Key: 256740527
• Report Number: 9681821-2020-00034
• 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
• Report Date: 07/06/2020

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: Other
• Device Expiration Date: 11/19/2022
• Device Model Number: N/A
• Device Catalogue Number: 185490
• Device Lot Number: GVGH078
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/06/2020
• Initial Date FDA Received: 08/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 38 YR