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

Model Number N/A

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

Patient Problem Hyperglycemia (1905)

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas) hyperglycaemia [hyperglycaemia] spring/piston rod in pen has not been pushing through medication [device malfunction] used same novofine needle up to 4 times [multiple use of single-use product] does not remove novofine needle when storing novopen echo [product storage error] this serious spontaneous case from (b)(6) was reported by a consumer as "hyperglycaemia(hyperglycaemia)" with an unspecified onset date, "spring/piston rod in pen has not been pushing through medication(device component malfunction)" with an unspecified onset date, "used same novofine needle up to 4 times(needle reusage)" with an unspecified onset date, "does not remove novofine needle when storing novopen echo(device stored with needle attached)" with an unspecified onset date, and concerned a elderly female patient who was treated with novopen echo (insulin delivery device) from unknown start date and ongoing for "diabetes", , novofine (needle) from unknown start date for "diabetes".Patient's height, weight and body mass index were not reported.Current condition: diabetes (for 61 years).Concomitant products included - novorapid penfill(insulin aspart) solution for injection, 100 u/ml, evista(raloxifene hydrochloride) treatment included - novorapid flexpen(insulin aspart) on an unknown date, spring/piston rod in pen had not been pushing through medication from novorapid penfill.As a result, patient developed hyperglycaemia with a blood sugar level of 27mmol/l for which patient was taken to hospital and admitted.No treatment was received in hospital as wait was too long.The patient was brought home by husband who found a novorapid flexpen that was used to bring down sugar levels.It was also mentioned that the patient does not remove novofine needle when storing novopen echo, and used the same needle up to 4 times.Batch number of novopen echo was gvge723-1.Batch number of novofine has been requested.Action taken to novopen echo was reported as no change.Action taken to novofine needle was not reported.The outcome for the event "hyperglycaemia(hyperglycaemia)" was recovered.The outcome for the event "spring/piston rod in pen has not been pushing through medication(device component malfunction)" was not reported.The outcome for the event "used same novofine needle up to 4 times(needle reusage)" was not reported.The outcome for the event "does not remove novofine needle when storing novopen echo(device stored with needle attached)" was not reported.Preliminary manufacturer's comment: (b)(6) 2021: the suspected device has been returned to novo nordisk for evaluation.Investigations ongoing.It is found that patient does not remove needle when storing pen and can use the same needle up to 4 times.These product handling error could have contributed to device malfunction which in turn affects insulin delivery and cause hyperglycaemia.

Event Description

Case description: this serious spontaneous case from australia was reported by a consumer as "hyperglycaemia(hyperglycaemia)" with an unspecified onset date, "spring/piston rod in pen has not been pushing through medication(device component malfunction)" with an unspecified onset date, "used same novofine needle up to 4 times(needle reusage)" with an unspecified onset date, "does not remove novofine needle when storing novopen echo(device stored with needle attached)" with an unspecified onset date, and concerned a elderly female patient who was treated with novopen echo (insulin delivery device) from unknown start date and ongoing for "diabetes", , novofine (needle) from unknown start date for "diabetes", , novorapid penfill (insulin aspart) solution for injection, 100 iu/ml, (dose, frequency & route used: unk (tid), unknown) from unknown start date for "diabetes", action taken to novorapid penfill was not reported.Investigation result: novopen echo red - batch gvge723-1.A visual examination of the returned product was performed.The device was returned with the cartridge and the needle from this case mounted.On receipt there was a gap between piston rod of the device and the rubber piston in the cartridge.If the user attempted to make an air shot or to dose prior to this no insulin would have been dispensed.The user either retracted the piston rod correctly during change of the cartridge, but mounted a partly used cartridge afterwards without ensuring contact between the piston rod and the rubber piston by following the air shot procedure, the user left the needle on the pen between injections, or the user retracted the piston rod between injections.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 results were found to comply with specifications.Novorapid® penfill® 3ml - batch kr76c44.A visual examination of the returned product was performed.The cartridge was tested with a random novopen echo and a novo nordisk needle was mounted.During testing it was possible to deliver preparation from the cartridge.The returned sample had been analysed chemically.The result was within acceptable limits.During examination of the product, no irregularities related to the complaint were detected.Novofine - batch unknown.Microscopic examination performed was performed.The needle was tested for flow with measure threads.The needle met specification.It had not been possible to observe the alleged fault.Since last submission the case has been updated with the following: -novorapid penfill updated from concomitant medication to suspect -investigation result updated.-"is non-reportable" field updated to "no" -final report checked in eu/ca device tab -annex b, c, d, g codes updated in device addendum tab -manufacturer's comment updated -narrative updated accordingly.Preliminary manufacturer's comment: (b)(6) 2021: the suspected device (novopen echo red) has been returned to novo nordisk for evaluation.Investigations ongoing.It is found that patient does not remove needle when storing pen and can use the same needle up to 4 times.There was a gap between the rubber piston and the piston rod washer.These product handling error could have contributed to device malfunction which in turn affects insulin delivery and cause hyperglycaemia.(b)(6) 2021: the suspected device (novofine needles) has been returned to novo nordisk for evaluation.Investigations ongoing.It is found that patient does not remove needle when storing pen and can use the same needle up to 4 times.The needle was returned without needle cap on.No other remarks on the needle.These product handling error could have contributed to device malfunction which in turn affects insulin delivery and cause hyperglycaemia.H3 continued: evaluation summary: investigation result: novopen echo red - batch gvge723-1.A visual examination of the returned product was performed.The device was returned with the cartridge and the needle from this case mounted.On receipt there was a gap between piston rod of the device and the rubber piston in the cartridge.If the user attempted to make an air shot or to dose prior to this no insulin would have been dispensed.The user either retracted the piston rod correctly during change of the cartridge, but mounted a partly used cartridge afterwards without ensuring contact between the piston rod and the rubber piston by following the air shot procedure, the user left the needle on the pen between injections, or the user retracted the piston rod between injections.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 results were found to comply with specifications.

Event Description

Since last submission the case has been updated with the following: -investigation result updated.-"is non-reportable" field updated to "no".-final report checked in eu/ca device tab.-annex b, c, d, g codes updated in device addendum tab.-manufacturer's comment updated.-narrative updated accordingly.Final manufacturer's comment: (b)(6) 2021: the suspected device (novopen echo red) has been returned to novo nordisk for evaluation.Upon investigation, device was found to work as specified.No device problem found.It is found that patient does not remove needle when storing pen and can use the same needle up to 4 times.There was a gap between the rubber piston and the piston rod washer.The fault may not be obvious to the user.Dose accuracy may be affected if the user uses the pen despite the fault.If the air gap is correctly equalized, dose accuracy is not affected.Failure to equalize a large air gap before dosing may cause several instances of no dose of drug, which for all the drug products covered by this code may result in hyperglycaemia.(b)(6) 2021: the suspected device (novofine needles) has been returned to novo nordisk for evaluation.The needles were tested for flow with measure threads.The needle met specification.One used needle with a hook on front needle.The observed fault is a result of accidental damage during use.It is found that patient does not remove needle when storing pen and can use the same needle up to 4 times.The needle was returned without needle cap on.No other remarks on the needle.These product handling error could have contributed to device malfunction which in turn affects insulin delivery and cause hyperglycaemia.Company comment: reported events are listed.This single case report is not considered to change the current knowledge of the safety profile of novorapid penfill.

• Brand Name: NOVOPEN ECHO
• Type of Device: INSULIN DELIVERY DEVICE
• Manufacturer (Section D): NOVO NORDISK A/S, MEDICAL SYSTEMS; hilleroed, ; DA
• MDR Report Key: 11992447
• MDR Text Key: 256072015
• Report Number: 9681821-2021-00026
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• PMA/PMN Number: K123766
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 05/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 185459
• Device Lot Number: GVGE723-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2021
• Date Manufacturer Received: 07/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: EVISTA (RALOXIFENE HYDROCHLORIDE).; NOVORAPID PENFILL (INSULIN ASPART).; EVISTA (RALOXIFENE HYDROCHLORIDE); NOVORAPID PENFILL (INSULIN ASPART)
• Patient Outcome(s): Hospitalization