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Model Number UNKNOWN |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problems
Hyperglycemia (1905); Pain (1994); Visual Impairment (2138); Missed Dose (2561); Abdominal Distention (2601)
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Event Date 03/10/2016 |
Event Type
Injury
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Manufacturer Narrative
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Since the device is not being returned, evaluation for a malfunction is not possible.A follow-up report will be submitted when the final evaluation is completed.
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Event Description
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(b)(4).This spontaneous case, reported by a consumer who contacted the company to report an adverse event with a product complaint, concerns an adult female patient of unknown origin who was (b)(6).The medical history of patient included type 2 diabetes mellitus since she was (b)(6) described as genetic and her father and her sister also had type 2 diabetes mellitus.The concomitant medications included unspecified drugs to sleep, insulin glargine via reusable pen and metformin for unknown indications.The patient received insulin lispro (humalog) vial via syringe, maximum dose of 8 iu at 15 minutes prior to lunch (dose according to glycemia), occasionally more than one dose per day if glycemia was high, subcutaneously, for treatment of type 2 diabetes mellitus, beginning in 2015.In 2015, unknown if after or prior to the starting of insulin lispro, the patient experienced very bad vision.Information regarding exams was not provided.Approximately on (b)(6) 2016 the patient started to use humapen luxura (unknown body type pen) in order to deliver the concomitant medication insulin glargine.On an unspecified date, unknown if after or prior to the starting of insulin lispro (via syringe) and humapen luxura (unknown body type pen), the patient experienced injection site pain.According to reporting consumer the application was more painful in the thigh.Information regarding corrective treatment and outcome of injection site pain was not provided.On (b)(6) 2016, unknown exact time after the starting of insulin lispro and humapen luxura (unknown body type pen) (unknown lot number), the glycemia of patient was very high (no value was provided), she almost experienced coma and she was hospitalized as corrective measure.According to reporting consumer the humapen luxura (unknown body type) was not releasing the insulin glargine and it was noted only after the patient experienced the blood glucose increased.It was provided that glycated hemoglobin reached 11.75 (measure unit was not provided) even the patient underwent an unspecified diet.It was provided that the insulin lispro used at noon via syringe saved the patient (as reported).The patient was discharged from hospital on the following day.It was also provided that she had a worsening of her bad vision during the hospitalization and she had her knee distended at hospital due to the high glycemia (as reported).The patient would need to undergo an unspecified surgery due to the distended knee and she wore eyeglasses as corrective treatment for bad vision.Information regarding corrective treatment and outcome of distended knee and glycosylated hemoglobin increased was not provided and the event of distended knee was considered serious by the company due to medically significant reason.The patient was not recovered from the bad vision and it was unknown if she recovered from the events of high glycemia and drug dose omission.In (b)(6) 2016, reported on (b)(6) 2016 as some days ago, the reporting consumer noted that the humapen luxura (unknown body type) was damaged and it was not releasing the insulin.On an unspecified date the patient stopped to use this reusable pen because she became afraid of it (as reported).The patient never performed the prime step of the reusable pen and she would visit the physician on (b)(6) 2016 in order to show a magnetic resonance (as reported) whose result was provided.Treatment with insulin lispro was continued.The patient operated the device and she learned to use it through the user manual.The patient had used the device model and the reported device for approximately 20 days and she stopped to use after its issue.Since the device is not being returned, evaluation for a malfunction is not possible.The reporting consumer did not consider the event of bad vision related to insulin lispro and did not provide a relatedness opinion between insulin lispro and the remaining events.The reporting consumer also stated that drug dose omission was due to the problem of humapen luxura (unknown body type), the event of blood glucose increased occurred due to the drug dose omission and the event of knee distended was related to the high glycemia.Edit 30mar2016.Case was opened to enter medwatch device fields for device mailing.No new information.
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Manufacturer Narrative
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New, updated and corrected information is referenced within the update statements.No further follow up is planned.Evaluation summary a female patient reported that her humapen luxura device was not releasing insulin.She experienced increased blood glucose levels.The device was not returned to the manufacturer for investigation (batch unknown).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.However, based on the patient's complaint description, the patient reported using a non-lilly insulin cartridge in the device.The user manual instructs, [?]humapen luxura is for use only with lilly insulin (humalog or humulin) 3 ml cartridges.Do not use other brands of insulin cartridges.' there is evidence of improper use.The patient used non-lilly insulin cartridge in the device.In addition, the patient did not prime the device and did not hold the injection button down for 5 seconds.This may be relevant to the complaint of increased blood glucose levels.
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Event Description
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(b)(4).This spontaneous case, reported by a consumer who contacted the company to report an adverse event with a product complaint, concerns an adult female patient of unknown origin who was born on (b)(6).The medical history of patient included type 2 diabetes mellitus since she was (b)(6) described as genetic and her father and her sister also had type 2 diabetes mellitus.The concomitant medications included unspecified drugs to sleep, insulin glargine via reusable pen and metformin for unknown indications.The patient received insulin lispro (humalog) vial via syringe, maximum dose of 8 iu at 15 minutes prior to lunch (dose according to glycemia), occasionally more than one dose per day if glycemia was high, subcutaneously, for treatment of type 2 diabetes mellitus, beginning in 2015.In 2015, unknown if after or prior to the starting of insulin lispro, the patient experienced very bad vision.Information regarding exams was not provided.Approximately on (b)(6) 2016 the patient started to use humapen luxura (unknown body type pen) in order to deliver the concomitant medication insulin glargine.On an unspecified date, unknown if after or prior to the starting of insulin lispro (via syringe) and humapen luxura (unknown body type pen), the patient experienced injection site pain.According to reporting consumer the application was more painful in the thigh.Information regarding corrective treatment and outcome of injection site pain was not provided.On (b)(6) 2016, unknown exact time after the starting of insulin lispro and humapen luxura (unknown body type pen) (unknown lot number), the glycemia of patient was very high (no value was provided), she almost experienced coma and she was hospitalized as corrective measure.According to reporting consumer the humapen luxura (unknown body type) was not releasing the insulin glargine and it was noted only after the patient experienced the blood glucose increased.It was provided that glycated hemoglobin reached 11.75 (measure unit was not provided) even the patient underwent an unspecified diet.It was provided that the insulin lispro used at noon via syringe saved the patient (as reported).The patient was discharged from hospital on the following day.It was also provided that she had a worsening of her bad vision during the hospitalization and she had her knee distended at hospital due to the high glycemia (as reported).The patient would need to undergo an unspecified surgery due to the distended knee and she wore eyeglasses as corrective treatment for bad vision.Information regarding corrective treatment and outcome of distended knee and glycosylated hemoglobin increased was not provided and the event of distended knee was considered serious by the company due to medically significant reason.The patient was not recovered from the bad vision and it was unknown if she recovered from the events of high glycemia and drug dose omission.In (b)(6) 2016, reported on (b)(6) 2016 as some days ago, the reporting consumer noted that the humapen luxura (unknown body type) was damaged and it was not releasing the insulin.On an unspecified date the patient stopped to use this reusable pen because she became afraid of it (as reported).The patient never performed the prime step of the reusable pen and she would visit the physician on (b)(6) 2016 in order to show a magnetic resonance (as reported) whose result was provided.Treatment with insulin lispro was continued.The patient operated the device and she learned to use it through the user manual.The patient had used the device model and the reported device for approximately 20 days and she stopped to use after its issue.The device was not returned.The reporting consumer did not consider the event of bad vision related to insulin lispro and did not provide a relatedness opinion between insulin lispro and the remaining events.The reporting consumer also stated that drug dose omission was due to the problem of humapen luxura (unknown body type), the event of blood glucose increased occurred due to the drug dose omission and the event of knee distended was related to the high glycemia.Edit 30mar2016.Case was opened to enter medwatch device fields for device mailing.No new information.Update 21apr2016: additional information received on 21apr2016 from the global product complaint database added the device specific safety summary; added the device was not returned; updated the medwatch and european and canadian required device reporting elements; and updated the narrative.
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