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Model Number MS8929 |
Device Problems
Mechanical Jam (2983); Insufficient Information (3190)
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Patient Problem
Hyperglycemia (1905)
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Event Date 02/28/2021 |
Event Type
Injury
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Manufacturer Narrative
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If device is returned, evaluation will be performed to determine if a malfunction has occurred.This is an initial report.A follow-up report will be submitted when the final evaluation is completed.
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Event Description
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Lilly case id: (b)(6).This report is associated with product complaint: (b)(4).This spontaneous case, reported by a consumer who contacted the company to report adverse events and product complaint (pc), concerns a 65-years-old asian male patient of han origin.Medical history included a blood stasis in his ear and his ears were not good.Family medical history included sister of uncle family, and the patient own sister all had diabetes.No previous drug adverse reaction or no family drug adverse reaction were reported.Concomitant medications included acarbose used for unknown indication, miglitol used as hypoglycemic agent and drugs for promoting blood circulation and removing blood stasis (for treatment of ears, specific drug name was not informed).The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) injections (humulin 70/30) from a cartridge via a reusable device (humapen ergo, teal/clear), 7 units each morning, subcutaneously, for the treatment of diabetes mellitus, beginning in 2016 or 2017 (conflicting year provided).The device was started in approximately 2016 or 2017 and the patient stored the device with the needle attached, considered as improper use and storage (ius).On an unspecified date approximately in 2019, after starting human insulin isophane suspension 70%/human insulin 30%, he experienced issues due to worsening of his hearing problems.His poor hearing was slowly aggravating every year.Since an unknown date, he also experienced issues with eyesight and tinnitus.On an unknown date, the injection button of the humapen ergo, was difficult to press down and could not be pressed down after insulin was used off and replaced with new cartridge ((b)(4), lot 0312a01).Approximately in (b)(6) 2021, his diabetes aggravated and he was hospitalized due to hearing impairment aggravated, visual impairment, tinnitus and diabetes aggravated.At hospital, he was treated for eyes, ears and his blood glucose was controlled.His eyesight was restored to normal after the treatment.The doctor prescribed unspecified medicines that promoted blood circulation and eliminated blood stasis for treating the ears, but the ear hearing did not improve.The blood glucose was under control when he was discharged and the dosage of human insulin isophane suspension 70%/human insulin 30% was changed according to the doctor advice to: twice a day, 10 in the morning, and 8 in the evening.Since an unknown date, he sometimes experienced hypoglycemia (values, units and reference range not provided) at night when he ate late.He was uncomfortable and unwell when he had hypoglycemia however this condition was restored when he ate something in morning.Further information regarding hospitalization, corrective treatment, discharge date, and outcome of the remaining events was not provided.Treatment status of human insulin isophane suspension 70%/human insulin 30% was ongoing.The operator of humapen ergo was the patient, and his training status was not provided.The general device duration of use for humapen ergo was approximately 7 or 8 years however the suspect humapen ergo device duration of use was not reported.The suspect device status was available, and its return was expected.The reporting consumer did not know if the events were related to human insulin isophane suspension 70%/human insulin 30% drug and did not provide any relatedness with the humapen ergo device.Update 09-jan-2024: additional information was received from affiliate on 09-jan-2023.Received and processed product complaint number: (b)(4).No further changes were made to the case.Edit 12-jan-2024: upon internal review from information received on 03-jan-2024, amended ius from no to yes, described ius in narrative, and amended the narrative to describe the product complaint description.Edit 18jan2024: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.
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Event Description
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Lilly case id: (b)(4).This report is associated with product complaint: (b)(4).This spontaneous case, reported by a consumer who contacted the company to report adverse events and product complaint (pc), concerns a 65-years-old asian male patient of han origin.Medical history included a blood stasis in his ear and his ears were not good.Family medical history included sister of uncle family, and the patient own sister all had diabetes.No previous drug adverse reaction or no family drug adverse reaction were reported.Concomitant medications included acarbose used for unknown indication, miglitol used as hypoglycemic agent and drugs for promoting blood circulation and removing blood stasis (for treatment of ears, specific drug name was not informed).The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) injections (humulin 70/30) from a cartridge via a reusable device (humapen ergo, teal/clear), 7 units each morning, subcutaneously, for the treatment of diabetes mellitus, beginning in 2016 or 2017 (conflicting year provided).The device was started in approximately 2016 or 2017 and the patient stored the device with the needle attached, considered as improper use and storage (ius).On an unspecified date approximately in 2019, after starting human insulin isophane suspension 70%/human insulin 30%, he experienced issues due to worsening of his hearing problems.His poor hearing was slowly aggravating every year.Since an unknown date, he also experienced issues with eyesight and tinnitus.On an unknown date, the injection button of the humapen ergo, teal/clear pen body type, was difficult to press down and could not be pressed down after insulin was used off and replaced with new cartridge ((b)(4), lot 0312a01).Approximately in feb-2021, his diabetes aggravated and he was hospitalized due to hearing impairment aggravated, visual impairment, tinnitus and diabetes aggravated.At hospital, he was treated for eyes, ears and his blood glucose was controlled.His eyesight was restored to normal after the treatment.The doctor prescribed unspecified medicines that promoted blood circulation and eliminated blood stasis for treating the ears, but the ear hearing did not improve.The blood glucose was under control when he was discharged and the dosage of human insulin isophane suspension 70%/human insulin 30% was changed according to the doctor advice to: twice a day, 10 in the morning, and 8 in the evening.Since an unknown date, he sometimes experienced hypoglycemia (values, units and reference range not provided) at night when he ate late.He was uncomfortable and unwell when he had hypoglycemia however this condition was restored when he ate something in morning.Further information regarding hospitalization, corrective treatment, discharge date, and outcome of the remaining events was not provided.Treatment status of human insulin isophane suspension 70%/human insulin 30% was ongoing.The operator of humapen ergo, teal/clear pen body type was the patient, and his training status was not provided.The general device duration of use for humapen ergo, teal/clear pen body type was approximately 7 or 8 years however the suspect humapen ergo, teal/clear pen body type device duration of use was not reported.The suspect device status was available, and was returned to manufacturer.The reporting consumer did not know if the events were related to human insulin isophane suspension 70%/human insulin 30% drug and did not provide any relatedness with the humapen ergo, teal/clear pen body type device.Update 09-jan-2024: additional information was received from affiliate on 09-jan-2023.Received and processed product complaint number: (b)(4).No further changes were made to the case.Edit 12-jan-2024: upon internal review from information received on 03-jan-2024, amended ius from no to yes, described ius in narrative, and amended the narrative to describe the product complaint description.Edit 18jan2024: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 22jan2024: additional information received on 15jan2024 from global product complaint database.Updated the lot number from unknown to 0312a01 and updated the unknown model number to ms8929 related to the suspect device humapen ergo, teal/clear relating to pc number (b)(4).Added product return date and number.Corresponding fields and narrative updated accordingly.Update 07feb2024: additional information received on 05feb2024 from the global product complaint database.Entered the device specific safety summary (dsss); updated the medwatch and european and canadian (eu/ca) device fields, malfunction from unknown to no, suspect device ergo, teal/clear associated with pc (b)(4).Corresponding fields and narrative updated accordingly.Edit 09feb2024: upon internal review, edited device distributed within the following countries in medwatch fields.No new information processed.
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Manufacturer Narrative
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Please refer to update statements(s) dated 07feb2024 in the b.5.Field.No further follow-up is planned.Evaluation summary: a patient's family member and a patient reported that "the injection button of a humapen ergo was difficult to press down when using it with a cartridge (the specific malfunction time was unknown) and it could not be pressed down after the insulin was used off and replaced a new cartridge." after the needle was replaced, the injection button could still not be pressed down.The patient experienced diabetes mellitus.The investigation of the returned device (batch 0312a01, manufactured december 2003) found the device met functional requirements and met dose accuracy and glide (injection) force specifications.No malfunction was identified.The patient used the device since 2016 or 2017, approximately 7 or 8 years.The core instructions for use state the humapen ergo has been designed to be used for up to 3 years after first use.The patient stored the device with the needle attached.The core instructions for use state to remove the needle after every use.There is evidence of improper use.The patient used the device beyond the recommended use period.This misuse is not likely relevant to the complaint since the device functioned normally.The patient stored the device with the needle attached.It is unknown if this misuse is relevant to the complaint or the adverse event.
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Search Alerts/Recalls
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