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| Model Number N/A |
| Device Problems
Labelling, Instructions for Use or Training Problem (1318); Device Difficult to Setup or Prepare (1487); Failure to Deliver (2338); Delivery System Failure (2905); Device Operates Differently Than Expected (2913); Infusion or Flow Problem (2964); No Flow (2991)
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| Patient Problems
Bacterial Infection (1735); Hyperglycemia (1905); Unspecified Infection (1930); Diabetic Ketoacidosis (2364)
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| Event Date 10/12/2017 |
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Event Type
Injury
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Event Description
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Diabetic ketoacidosis [diabetic ketoacidosis], hyperglycaemia [hyperglycaemia], the test is performed with the piston rod in the position indicated by the manufacturer, it did not trigger when the dose button was activated and therefore the insulin did not flow out [device failure], did not follow the instructions in the insert regarding testing the insulin flow before injecting the insulin [wrong technique in product usage process].
Case description: this serious spontaneous regulatory authority case received via (b)(6) from (b)(6) was reported by a consumer as "diabetic ketoacidosis" with an unspecified onset date, "hyperglycemia " with an unspecified onset date, "the test is performed with the piston rod in the position indicated by the manufacturer, it did not trigger when the dose button was activated and therefore the insulin did not flow out" with an unspecified onset date, "did not follow the instructions in the insert regarding testing the insulin flow before injecting the insulin" with an unspecified onset date, and concerned a female patient (age between 10-18 years) who was treated with novopen 4 (insulin delivery device) from unknown start date due to "device therapy", actrapid penfill (insulin human) from unknown start date and ongoing for unknown indication" and unknown dose and frequency, insulatard penfill (insulin human) from unknown start date and ongoing for unknown indication and unknown dose and frequency.
Patient's height, weight and body mass index: not reported.
Medical history was not provided.
It was reported that the patient had diabetic ketoacidosis, a few days after the patient started using penfill and novopen 4.
It was reported that when the test was performed with the piston rod in the position indicated by the manufacturer, it did not trigger when the dose button was activated and therefore the insulin did not flow out, leading to problems in the application of the medication causing hyperglycemia.
The patient was recovered and then the device was changed and the patient was retrained in the use of penfill and novopen 4.
Also, it was reported that the patient did not follow the instructions in the insert regarding testing the insulin flow before injecting the insulin.
Action taken to novopen 4 was not reported.
Action taken to actrapid penfill was not reported.
Action taken to insulatard penfill was not reported.
The outcome for the event "diabetic ketoacidosis" was recovered.
The outcome for the event "hyperglycemia " was recovered.
The outcome for the event "the test is performed with the piston rod in the position indicated by the manufacturer, it did not trigger when the dose button was activated and therefore the insulin did not flow out" was not reported.
The outcome for the event "did not follow the instructions in the insert regarding testing the insulin flow before injecting the insulin" was not reported.
This case is linked to (b)(4) (same reporter).
Company comment: in this case the reported events are listed.
More details are needed for the proper medical evaluation.
Reporter comment: the moh classified the events as related to novopen 4, not to the insulins (actrapid and insulatard).
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Event Description
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Case description: investigation result: name: novopen 4 - batch fvg9827-1.
Use a new needle for each injection.
The needle should be mounted immediately before the injection.
Always remove the used needle immediately after each injection and store the device without a needle attached.
Otherwise, temperature fluctuations may cause leakage through the needle, resulting in a space between the rubber piston in the cartridge and the piston rod in the device.
Furthermore, clogging of the needle may occur.
Finally, priming to expel air must always be performed before each injection, as stated in the package leaflet.
A batch record review on adr hyper + adr: misc.
Were found to be normal.
The product was not returned for examination.
The complaint has been registered in the novo nordisk complaint handling system.
Name: novopen 4 - batch fvg9876-1.
A batch record review on hyperglycaemia and adr: misc was found to be normal.
The product was not returned for examination.
The complaint has been registered in the novo nordisk complaint handling system.
Name: insulatard® penfill® 100 iu/ml - batch fs61b38.
The product was not returned for examination.
The complaint has been registered in the novo nordisk complaint handling system and a medical evaluation has been performed.
A reference were examined macroscopically and microscopically parameters identity, assay and degradation were also performed.
The reference sample was found to be normal.
The results were found to comply with specifications.
During investigation it has not been possible to detect any irregularities related to the complaint on a reference/retain sample of the batch in question.
Name: actrapid® penfill® 100 iu/ml - batch fs61b39.
The product was not returned for examination.
The complaint has been registered in the novo nordisk complaint handling system and a medical evaluation has been performed.
A reference were examined macroscopically parameters identity, assay and degra-dation were also performed.
The reference sample was found to be normal.
The results were found to comply with specifications.
During investigation it has not been possible to detect any irregularities related to the complaint on a reference/retain sample of the batch in question.
Since last submission, the case has been updated with the following: investigational results updated.
Manufacturer's comment updated.
Narrative updated accordingly.
Manufacturer's comment/company comment: 08-aug-2018: as the devices of novopen 4 (batch nos.
- fvg9827-1 and fvg9876-1) have not been returned to novo nordisk a/s for investigation and very limited information regarding the handling of suspected device is available, it is not possible to identify a clear root-cause of the experienced adverse event and thus find similar incidents to the one reported in (b)(4).
In this case the reported events diabetic ketoacidosis,hyperglycaemias,device failure, wrong technique in device usage process are listed and the events gingivostomatitis ,giardiasis are considered unlisted.
The diabetic ketoacidosis in this patient may have been triggered by the underlying bacterial and protozoal infections in the form of gingivostomatitis and giardiasis in this patient.
However more details are needed for the proper medical evaluation.
This single case report is not considered to change the current knowledge of the safety profile of insulatard and actrapid.
Evaluation summary: name: novopen 4 - batch fvg9827-1.
No investigation was possible, because neither sample nor batch number was available.
A batch record review on adr hyper + adr: misc.
Were found to be normal.
The product was not returned for examination.
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Event Description
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Case description: the (b)(6) cuba, reported to nn that 6 female patients between 10 - 18 years, presented diabetic ketoacidosis, a few days after the patients started using penfill.
This case concerns one of the 6 patients.
It was reported that this patient had diabetic ketoacidosis, a few days after the patient started using penfill and novopen 4.
It was reported that when the test was performed with the piston rod in the position indicated by the manufacturer, it did not trigger when the dose button was activated and therefore the insulin did not flow out, leading to problems in the application of the medication causing hyperglycemia.
Investigation result: name: novopen 4 - batch unknown.
No investigation was possible, because neither sample nor batch number was available.
Name: insulatard® penfill® 100 iu/ml - batch fs61b38.
The product was not returned for examination.
The complaint has been registered in the novo nordisk complaint handling system and a medical evaluation has been performed.
Name: actrapid® penfill® 100 iu/ml - batch fs61b39.
The product was not returned for examination.
The complaint has been registered in the novo nordisk complaint handling system and a medical evaluation has been performed.
Since last submission, the case has been updated with the below information: -investigation result updated.
-manufacturer comment updated.
-device codes updated.
-narrative updated accordingly.
Manufacturer's comment/company comment: 16-apr-2018: as the device novopen 4 has not been returned to novo nordisk a/s for investigation and very limited information regarding the handling of suspected device is available, it is not possible to identify a clear root-cause of the experienced adverse event and thus find similar incidents to the one reported in argus case (b)(4).
In this case the reported events are listed.
More details are needed for the proper medical evaluation.
This single case report is not considered to change the current knowledge of the safety profile of insulatard and actrapid.
H3 continued: evaluation summary: name: novopen 4 - batch unknown.
No investigation was possible, because neither sample nor batch number was available.
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Event Description
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Event verbatim [preferred term], gingivostomatitis [stomatitis], giardiasis [giardiasis], diabetic ketoacidosis [diabetic ketoacidosis], hyperglycaemia [hyperglycaemia].
The test is performed with the piston rod in the position indicated by the manufacturer, it did not trigger when the dose button was activated and therefore the insulin did not flow out' [device failure].
Did not follow the instructions in the insert regarding testing the insulin flow before injecting the insulin [wrong technique in product usage process].
At night she presented hyperglycaemia [hyperglycaemia].
Case description: this serious spontaneous regulatory case received via "ministry of health (cecmed)" from cuba was reported by a consumer and confirmed by a health care professional as "gingivostomatitis" beginning on (b)(6) 2017, "giardiasis" with an unspecified onset date, "diabetic ketoacidosis" beginning on (b)(6) 2017, "hyperglycaemia" with an unspecified onset date, "the test is performed with the piston rod in the position indicated by the manufacturer, it did not trigger when the dose button was activated and therefore the insulin did not flow out'" with an unspecified onset date, "did not follow the instructions in the insert regarding testing the insulin flow before injecting the insulin" with an unspecified onset date, "at night she presented hyperglycaemia" beginning on (b)(6) 2017, and concerned a 11 years old female patient who was treated with novopen 4 (insulin delivery device) from unknown start date due to "diabetes mellitus", novopen 4 (insulin delivery device) from unknown start date due to "diabetes mellitus", insulatard penfill (insulin human) from unknown start date and ongoing due to "diabetes mellitus" (regimen#1 unknown dose and frequency, regimen#2 dose and frequency 8 iu, qd), actrapid penfill (insulin human) from unknown start date and ongoing due to "diabetes mellitus" (regimen#1 unknown dose and frequency, regimen#2 dose and frequency 18 iu, qd).
Patient's weight: 37 kg (height and body mass index were not reported).
Medical history included diabetes mellitus (type and duration not reported), dengue with hepatic coagulopathy.
Treatment included - azithromycin (azithromycin 0.
5-ethanol monohydrate), cimetidine(cimetidine), ranitidine(ranitidine), insulin (insulin).
On (b)(6) 2017, the patient was diagnosed with gingivostomatitis and was treated with 1 tab of azithromycin.
On (b)(6) 2017, the patient went to hospital with a diagnosis of gingivostomatitis and diabetes mellitus treated with 18 iu daily of actrapid and 8 iu daily of nph.
The patient presented the first symptoms 2 days after starting the treatment with the new medicine.
It was associated with a giardiasis and a history of dengue with sequelae of hepatic coagulopathy.
The patient was treated with insulin bb in the hospital but on (b)(6) 2017, the patient was administered insulin with the pen at noon, at night the patient presented again hyperglycaemia and returned to treatment with insulin bb.
It was reported that this patient had diabetic ketoacidosis.
It was reported that when the test was performed with the piston rod in the position indicated by the manufacturer, it did not trigger when the dose button was activated and therefore the insulin did not flow out, leading to problems in the application of the medication causing hyperglycemia.
Ranitidine 1 tab each 12h was indicated for epigastric pain and, as it did not improve, treatment was changed to cimetidine on (b)(6) 2017 and again changed back to ranitidine.
The patient was recovered and then the device was changed and the patient was retrained in the use of penfill and novopen 4.
The patient did not follow the instructions in the insert regarding testing the insulin flow before injecting the insulin.
It was reported that the patient's mother reports that the patient injected herself, the medicine was kept cold and complies with the air ejection mechanism before administration, counts 6 seconds before removing the needle and determines the glucose before administering the medication.
At the time of delivery of the device in the hospital pharmacy, both the patient and the family received training for the use of the device by the licensees in charge.
The device was never delivered to relatives if the patients were not present (second training) on an unknown date, one girl said that she did not withdraw the needle at the end of the administration of the nph insulin when she used a new one in the first administration in the morning because she would use it in the remaining two applications of the day, but she always performed the disinfection.
At the time it was recommended to all patients that they should always remove the needle using the established technique.
No patient and family member reported that they had to make a different force to inject, making it easy to operate the dose button.
All patients used insulin suspension and stated that they always performed the re-suspension because they know it was the same type of insulin.
There were no changes reported in diet.
It was also reported that knowledge was shared related to the needle insertion angle and needle was inserted into the pen at a 180 degree angle.
It was always clarified in the trainings that although the manufacturer recommends storage at room temperature, in cuba it is never less than 30 degrees therefore, we recommended placing the penile near the water pommel that each one carried to the school, or keeping it in cool place at home.
All the diagnoses of ketoacidosis were issued by specialists in the hospital.
Action taken to novopen 4 was not reported.
Action taken to novopen 4 was not reported.
Action taken to insulatard penfill was not reported.
Action taken to actrapid penfill was not reported.
The outcome for the event "gingivostomatitis" was not reported.
The outcome for the event "giardiasis" was not reported.
The outcome for the event "diabetic ketoacidosis" was recovered.
The outcome for the event "hyperglycaemia" was recovered.
The outcome for the event "the test is performed with the piston rod in the position indicated by the manufacturer, it did not trigger.
When the dose button was activated and therefore the insulin did not flow out'" was not reported.
The outcome for the event "did not follow the instructions in the insert regarding testing the insulin flow before injecting the insulin" was not reported.
The outcome for the event "at night she presented hyperglycaemia" was not reported.
Reporter's comment: the moh classified the events as related to novopen 4, not to the insulins (actrapid and insulatard).
No patient and family member reported that they had to make a different force to inject, making it easy to operate the dose button in the practical demonstration of the devices in the room, individually with each patient, it was possible to witness the outflow of insulin before the administration of the drug and when the action was repeated without disassembling the needle and putting the supposed dose to be injected, there was no flow, evidencing that the spring did not exert any pressure on the penfill, although the clicks indicator returned to zero.
All the patients reported that they liked the administration of this insulin because it does not burn and this may be the reason why they did not realize they did not receive the medication.
It was reported that the patients were all trained, as well as the family members, by the pharmacist who carried out the dispensing of pen in the hospital pharmacy, who indeed was trained by the provincial pharmacoepidemiologist, who was present at the training carried out by the firm.
In this regard it was informed that during the monitoring of patients until discharge, were visited daily in the different services to verify their evolution and it was possible to verify with each of them the status of each device in a personal way and the mastery of the techniques of use, in a practical way.
This exchange served as a new training because at the time of delivery of the device in the hospital pharmacy, both the patient and the family received training for the use of it by the licensees in charge.
The device was never delivered to family members if patients were not present.
It was reported that several of the patients had received a first training months before, during their participation in the camp for diabetic children organized and directed by the head of endocrinology, which takes place annually in the summer vacation period.
From this first training there was much expectation with the beginning of the use of the new method of administration of insulins.
All the necessary training actions were carried out for patients and relatives by the pharmacoepidemiology network, taking into account that as representative, all the patients participated in the presentation of the product by the firm.
Also there was a training given to municipal pharmacoepidemiologists, hospital pharmacists and community pharmacies responsible for dispensing the device and the penfill.
Since last submission, the case has been updated with the below information: seriousness criteria for diabetic ketoacidosis, device failure, hyperglycaemia updated as hospitalisation.
New events hyperglycaemia night, gingivostomatitis and giardiasis added.
Indication for novopen 4 updated as diabetes mellitus.
Batch number of novopen 4 added (fvg9827 1, fvg98761).
Manufacturer's comment/company comment: on 20-jun-2018: as the device novopen 4 has not been returned to novo nordisk a/s for investigation and very limited information regarding the handling of suspected device is available, it is not possible to identify a clear root-cause of the experienced adverse event and thus find similar incidents to the one reported in argus case (b)(4).
In this case the reported events diabetic ketoacidosis,hyperglycaemias,device failure, wrong technique in device usage process are listed and the events gingivostomatitis ,giardiasis are considered unlisted.
The diabetic ketoacidosis in this patient may have been triggered by the underlying bacterial and protozoal infections in the form of gingivostomatitis and giardiasis in this patient.
However more details are needed for the proper medical evaluation.
This single case report is not considered to change the current knowledge of the safety profile of insulatard and actrapid.
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