MAUDE Adverse Event Report: NOVO NORDISK A/S, MEDICAL SYSTEMS NOVOPEN 3; INSULIN DELIVERY DEVICE

Model Number N/A

Device Problem Defective Device (2588)

Patient Problem Hyperglycemia (1905)

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas).Fasting blood glucose was high, 15 mmol/l [blood glucose increased].The dose window was blurry [device issue].Case description: this serious spontaneous case from china was reported by a consumer as "fasting blood glucose was high, 15 mmol/l(fasting blood glucose increased)" with an unspecified onset date, "the dose window was blurry(device component issue)" with an unspecified onset date, and concerned a 60 years old female patient who was treated with novopen 3 (insulin delivery device) from unknown start date for "type 2 diabetes mellitus", novolin 30r penfill (dose, frequency & route used-unk) (insulin human) from unknown start date for "type 2 diabetes mellitus".Patient's height, weight and body mass index were not reported.Current condition: type 2 diabetes mellitus (for over 10 years), hypertension (for about 10 years) historical condition: cerebral infarction.On an unknown date, patient's blood glucose was high 15 mmol/l and was hospitalized on (b)(6) 2023.The treatment plan was being adjusted.Since an unknown date, the patient reported that dose window of novopen 3 was blurry.Batch numbers: novolin 30r penfill: not reported.The reported batch number of novopen 3 yug0445 was invalid.Action taken to novopen 3 was not reported.Action taken to novolin 30r penfill was not reported.The outcome for the event "fasting blood glucose was high, 15 mmol/l(fasting blood glucose increased)" was not reported.The outcome for the event "the dose window was blurry(device component issue)" was not reported.

Event Description

Case description: since last submission, the case has been updated with the following: -eu/ca tab (final report date was updated to (b)(6)2023) on (b)(6)2023: the final report date has been updated since investigation results and imdrf codes of tresiba flextouch 200 u/ml are still under investigation.Preliminary manufacturer's comment: on (b)(6)2023: the suspected device novopen 3 has not been returned to novo nordisk for evaluation.No conclusion is reached.

Event Description

Case description: investigation result name: novopen® 3, batch number: yug0445 visual examination and functional testing were performed.Dirt was observed on the cartridge holder ,clip for cap , cap tube, piston rod lock, dosage selector, inside and outside the window, guidance tube.The dirty inside window can cause the dose indicator window blurred.The printing of batch number form"0" to "14" scale position on dose indicator barrel became lighter.The surface including logo of housing was worn.The dose accuracy was measured by weighing using a random cartridge.The result was within acceptable limits.Foreign dry matter observed on internal or external pen parts, e.G., dust, dirt, or dried liquid stains.The observed problem was not related to any novo nordisk processes and it was a result during use of the device.The pen had a minor fault which may impact on pen functions.The fault was caused by accidental damage during use of the device.The pen surface was worn.Scratches or dents in pen surfaces, or wear on printed or engraved figures on the pen surface caused by normal or rough use of the device.The fault had no impact on the mechanical functions of the pen.Name: novolin® 30r penfill®, batch number: unknown no investigation was possible, because neither sample nor batch number was available.Since last submission, the case has been updated with the following: investigation result added imdrf code added relevant fields updated in eu/ca tab narrative updated accordingly final manufacturer's comment: 02-jun-2023: the suspected device novopen 3 has been returned to novo nordisk for evaluation.Upon investigation, dirt was observed on the cartridge holder, clip for cap, cap tube, piston rod lock, dosage selector, inside and outside the window, guidance tube.The observed problem is not related to any novo nordisk processes and it is a result during use of the device.The pen has a minor fault which may impact on pen functions.The pen surface is worn, scratches or dents in pen surface noticed, which does not have any impact on the mechanical functions of the pen.Hyperglycaemia is listed.This single case report is not considered to change the current knowledge of the safety profile of novolin 30r penfill.H3 continued: evaluation summary name: novopen® 3, batch number: yug0445 visual examination and functional testing were performed.Dirt was observed on the cartridge holder ,clip for cap , cap tube, piston rod lock, dosage selector, inside and outside the window, guidance tube.The dirty inside window can cause the dose indicator window blurred.The printing of batch number form"0" to "14" scale position on dose indicator barrel became lighter.The surface including logo of housing was worn.The dose accuracy was measured by weighing using a random cartridge.The result was within acceptable limits.Foreign dry matter observed on internal or external pen parts, e.G., dust, dirt, or dried liquid stains.The observed problem was not related to any novo nordisk processes and it was a result during use of the device.The pen had a minor fault which may impact on pen functions.The fault was caused by accidental damage during use of the device.The pen surface was worn.Scratches or dents in pen surfaces, or wear on printed or engraved figures on the pen surface caused by normal or rough use of the device.The fault had no impact on the mechanical functions of the pen.

• Brand Name: NOVOPEN 3
• 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 3400
• Manufacturer Contact: p.o. box 846; plainsboro, NJ 08536 ; 8007276500
• MDR Report Key: 16625934
• MDR Text Key: 312116619
• Report Number: 9681821-2023-00039
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: 19-938
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: N/A
• Device Catalogue Number: 185290
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 05/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 60 YR
• Patient Sex: Female