Model Number MS9557 |
Device Problem
Mechanical Jam (2983)
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Patient Problem
Hyperglycemia (1905)
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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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(b)(4).This spontaneous case, reported by a consumer and a nurse via lilly china answer center (lcac), concerns an (b)(6) (at initial time of report) asian male patient.Medical history included a hypertension.Concomitant medication was not provided.The patient received human insulin (rdna origin) (humulin regular) via humapen ergo ii, reported as single dose (morning: 28; night: 28) (no units provided), twice a day, via subcutaneous route, for treatment of diabetes mellitus and beginning on an unknown date in 2013.On an unknown date, unknown time after starting human insulin, the patient experienced high blood glucose and was hospitalized on (b)(6) 2021 for regulating.Also, the reporting consumer and nurse reported that in (b)(6) 2021 or (b)(6) 2021 (specific date not provided), humapen ergo ii was not working well, was not easy to use, aged and was a bit jammed ((b)(4); lot number: unknown).Additionally, it was reported that the device had been in use for more than three years.On an unspecified date, the heel was a little pain when stepping.There was no tympanic membrane in his left ear and ear was not very good.Information regarding exams, corrective treatment and outcome was not provided.Human insulin treatment was ongoing.It was unknown who was the operator of device, and the training status was unknown.The duration of use for the device model and for the reported suspect device was approximately eight years.The reported device continued to be used and return status was unknown.The reporting consumer and nurse did not know if the events blood glucose increased and pain in extremity were related to human insulin therapy.The reporting consumer did not consider tympanic membrane disorder as related to human insulin therapy.Update 25-oct-2021: additional information was received from the initial reporting consumer on 20-oct-2021.Added two new non serious events of pain in heel and tympanic membrane disorder.Updated causality statement and accordingly updated narrative with new information.Edit 02nov2021: updated medwatch and european and (b)(6) (eu/(b)(6)) fields for expedited device reporting.No new information added.
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Manufacturer Narrative
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B.5.Narrative field: new, updated and corrected information is referenced within the update statements in b.5.Please refer to update statement dated 15nov2021 in the b.5.Field.No further follow-up is planned.Evaluation summary a patient's family and a nurse reported on behalf of a male patient reported that in (b)(6) 2021, the patient's humapen ergo ii device was not working well, was not easy to use, was aged, and was a bit jammed.The patient continued to use the device.The patient experienced increased blood glucose on (b)(6) 2021.The device was not returned to the manufacturer for investigation (batch number unknown).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.All humapen ergo ii devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality with high probability.The patient's family reported that the device had been used since about 2013.The core instructions for use state the humapen ergo ii has been designed to be used for up to 3 years after first use.In addition, the patient continued to use the device after experiencing the alleged complaint issue.The core instructions for use state if any of the parts of your humapen ergo ii appear broken or damaged, do not use.The core instructions for use also states to always carry a spare insulin pen in case your pen is lost or damaged.There is evidence of improper use.The patient used the device beyond the recommended use period and continued to use the device after experiencing the complaint issue.It is unknown if these misuses are relevant to the event of increased blood glucose.
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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 and a nurse via lilly china answer center (lcac), concerns an 85-year-old (at initial time of report) asian male patient.Medical history included a hypertension.Concomitant medication was not provided.The patient received human insulin (rdna origin) (humulin regular) via humapen ergo ii, reported as single dose (morning: 28; night: 28) (no units provided), twice a day, via subcutaneous route, for treatment of diabetes mellitus and beginning on an unknown date in 2013.On an unknown date, unknown time after starting human insulin, the patient experienced high blood glucose.Also, the reporting consumer and nurse reported that in (b)(6) 2021 (specific date not provided), humapen ergo ii was not working well, was not easy to use, aged and was a bit jammed (product complaint number: (b)(4); lot number: unknown).Additionally, it was reported that the device had been in use for more than three years.Then on (b)(6) 2021 the patient was hospitalized for high blood glucose for regulating.On an unspecified date, the heel was a little pain when stepping.There was no tympanic membrane in his left ear and ear was not very good.Information regarding exams, corrective treatment and outcome was not provided.Human insulin treatment was ongoing it was unknown who was the operator of device, and the training status was unknown.The duration of use for the device model and for the reported suspect device was approximately eight years.The reported device was continued to be used after the complaint.The suspect humapen ergo ii (unknown lot) device associated with product complaint (b)(4) was not returned to the manufacturer.The reporting consumer and nurse did not know if the events blood glucose increased and pain in extremity were related to human insulin therapy.The reporting consumer did not consider tympanic membrane disorder as related to human insulin therapy.The reporting consumer and nurse did not know if blood glucose increased was related to use of humapen ergo ii.The events of pain in extremity and tympanic membrane disorder were not associated with the use of humapen ergo ii.Update 25-oct-2021: additional information was received from the initial reporting consumer on 20-oct-2021.Added two new non serious events of pain in heel and tympanic membrane disorder.Updated causality statement and accordingly updated narrative with new information.Edit 02nov2021: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 15nov2021:additional information received on 09nov2021 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields/ european and canadian (eu/ca) device information and added device age for suspect humapen ergo ii (unknown lot) device associated with product complaint (b)(4) which was not returned to the manufacturer.Corresponding fields and narrative updated accordingly.Edit 19nov2021: upon review, this case was unlocked to update relatedness assessment in the narrative for the device humapen ergo ii.
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Search Alerts/Recalls
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