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).
|