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

Model Number N/A

Device Problem Failure to Fire (2610)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas) difficult to stabilize diabetes [diabetes mellitus inadequate control].The pen didn't deliver the indicated dose [incorrect dose administered by device].Device failure [device failure].Defective pen [device defective].Case description: this serious spontaneous case from (b)(6) was reported by a pharmacist as "difficult to stabilize diabetes" with an unspecified onset date, "the pen didn't deliver the indicated dose" with an unspecified onset date, "device failure" with an unspecified onset date, "defective pen" with an unspecified onset date, and concerned a child female patient who was treated with novopen echo (insulin delivery device) from unknown start date due to "device therapy", novopen echo (insulin delivery device) from unknown start date due to "device therapy".Patient's height, weight and body mass index not reported.Medical history included type 1 diabetes mellitus (duration not reported).Concomitant products included - novorapid penfill(insulin aspart) solution for injection, 100 u/ml, levemir penfill(insulin detemir) solution for injection,.0024 mol/l, glucagen(glucagon) powder and solvent for solution for injection, 1 mg on an unknown date, patients had difficulty in stabilizing diabetes, could be due to defective pen didn't deliver the indicated dose, results in hospitalization and was also experiencing malaise, later stabilized.The patient also reported device failure.Patient was discharged on same day.Batch number of novopen echo was available.Action taken to novopen echo was reported as unknown.The outcome for the event "difficult to stabilize diabetes" was recovering/resolving.The outcome for the event "the pen didn't deliver the indicated dose" was not reported.The outcome for the event "device failure" was not reported.The outcome for the event "defective pen" was not reported.Investigational results: name: novopen® echo® rouge, batch number: gvgg159-5.The batch documentation was reviewed.No abnormalities relating to the observed problem were found.The electronic register was checked.Several mitigation codes indicating use of a blocked/ broken needle were present.Visual and functional examinations were performed.The device was tested with a random cartridge and a novo nordisk needle was mounted.During testing it was possible to deliver preparation from the cartridge.The dose accuracy was measured by weighing using a random cartridge.The results were found to comply with specifications.The memory data in the device has revealed that the memory display has shown two lines (- -) after an attempted injection during use.The observed problem is caused by the use of a clogged needle on the pen.After the injection to follow the memory display will function normally again, if the injection needle is changed to a new one.The fault is caused by incorrect handling during use of the device.The batch documentation was reviewed.No abnormalities relating to the observed problem were found.The production interval for the batch gvgg159-5 and hvgm014-6 was about 10 months, at the same time, based on analysis including assembling process, packaging process, warehouse handling process, it was not possible for a 5-item pen mixing into a different batch carton.The packaging batch records of the involved batch numbers were checked.The batch records show that documentation regarding line clearance, control equipment and process checks were found to be acceptable.Batch number gvgg159-5 was packaged on 2017.11.04, and hvgm014-6 was packaged on 2018.08.30.As can be seen, there is almost 10 months between the packaging of the batches.We can therefore rule out that a mix-up has occurred at novo nordisk (b)(4).The observed problem is due to incorrect handling during use.Name: novopen® echo® rouge, batch number: hvgm014-6.The batch documentation was reviewed.No abnormalities relating to the observed problem were found.The production interval for the batch gvgg159-5 and hvgm014-6 was about 10 months, at the same time, based on analysis including assembling process, packaging process, warehouse handling process, it was not possible for a 5-item pen mixing into a different batch carton.The packaging batch records of the involved batch numbers were checked.The batch records show that documentation regarding line clearance, control equipment and process checks were found to be acceptable.Batch number gvgg159-5 was packaged on 2017.11.04, and hvgm014-6 was packaged on 2018.08.30.As can be seen, there is almost 10 months between the packaging of the batches.We can therefore rule out that a mix-up has occurred at novo nordisk (b)(4).The observed problem is due to incorrect handling during use.Manufacturer comment: 14-aug-2019: upon investigation of returned novopen echo, the memory data in the device has revealed that the memory display has shown two lines (- -) after an attempted injection during use.The observed problem is caused by the use of a clogged needle on the pen.The device was tested with a random cartridge and a novo nordisk needle was mounted.During testing it was possible to deliver preparation from the cartridge.Continued: evaluation summary.Name: novopen® echo® rouge, batch number: hvgm014-6.The batch documentation was reviewed.No abnormalities relating to the observed problem were found.The production interval for the batch gvgg159-5 and hvgm014-6 was about 10 months, at the same time, based on analysis including assembling process, packaging process, warehouse handling process, it was not possible for a 5-item pen mixing into a different batch carton.The packaging batch records of the involved batch numbers were checked.The batch records show that documentation regarding line clearance, control equipment and process checks were found to be acceptable.Batch number gvgg159-5 was packaged on 2017.11.04, and hvgm014-6 was packaged on 2018.08.30.As can be seen, there is almost 10 months between the packaging of the batches.We can therefore rule out that a mix-up has occurred at novo nordisk (b)(4).The observed problem is due to incorrect handling during use.

• Brand Name: NOVOPEN ECHO
• Type of Device: INSULIN DELIVERY DEVICE
• Manufacturer (Section D): NOVO NORDISK A/S, MEDICAL SYSTEMS; hilleroed, ; DA
• Manufacturer (Section G): NOVO NORDISK A/S; krogshoejvej 55; bagsvaerd 2880, ; DA
• Manufacturer Contact: p.o. box 846; plainsboro, NJ 08536 ; 8007276500
• MDR Report Key: 8915037
• MDR Text Key: 159838531
• Report Number: 9681821-2019-00057
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K123766
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial
• Report Date: 06/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/01/2020
• Device Model Number: N/A
• Device Catalogue Number: 185459
• Device Lot Number: HVGM014-6
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/23/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2018
• 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