Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Device Fell (4014)
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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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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, concerned an (b)(6) (at the time of initial report) chinese han patient of unknown gender.Medical history was not provided.Concomitant medications included the use of metformin for the treatment of an unknown indication.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) (humulin 70/30) from a cartridge, via a reusable pen (unknown), subcutaneously, for the treatment of diabetes mellitus, beginning on an unknown date in 2001.On an unknown date, while on the therapy with human insulin isophane suspension 70%/human insulin 30%, the patient had high blood glucose and high blood pressure due to which the patient was hospitalized on (b)(6) 2021.As on (b)(6) 2021, the patient was still in the hospital.Information regarding corrective treatment and outcome of events was not provided.Therapy status with human insulin isophane suspension 70%/human insulin 30% was not provided.No additional follow-up would be pursued, as the reporter refused further follow-up and the physician contact information was unknown.The operator of the device was the patient and his/her training status was not provided.The general device duration of use and suspect device duration of use was not provided.The issue with the suspect humapen had been not been resolved and its return was expected.The initial reporting consumer assessed the relatedness of the event to the human insulin isophane suspension 70%/human insulin 30% therapy as unknown.The initial reporting consumer did not provide the relatedness assessment of the events to the device use.Edit 07-jan-2022: updated medwatch fields for expedited device reporting and added contact log accordingly.No new information added.Edit 12-jan-2022: corrected suspect device name in device use paragraph in the narrative.
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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, concerned an 80-year-old(at the time of initial report)chinese han patient of unknown gender.Medical history was not provided.Concomitant medications included the use of metformin for the treatment of an unknown indication.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) (humulin 70/30) from a cartridge, subcutaneously, for the treatment of diabetes mellitus, beginning on an unknown date in 2001.In the end of (b)(6) 2021, the patient accidentally dropped and broke the injection pen, and it was barely in use.On (b)(6) 2021, the injection pen was completely broken, thus it could not be used.((b)(4) and lot number unknown).On an unknown date, while on the therapy with human insulin isophane suspension 70%/human insulin 30% via unknown injection pen from eli lilly, the patient had high blood glucose and high blood pressure due to which the patient was hospitalized on (b)(6) 2021.As on (b)(6) 2021, the patient was still in the hospital.Information regarding corrective treatment and outcome of events was not provided.Therapy status with human insulin isophane suspension 70%/human insulin 30% was not provided.No additional follow-up would be pursued, as the reporter refused further follow-up and the physician contact information was unknown.The operator of the device was the patient and his/her training status was not provided.The general device duration of use and suspect device duration of use was not provided.The issue with the suspect humapen had not been resolved and it was not returned to manufacturer.The initial reporting consumer assessed the relatedness of the event to the human insulin isophane suspension 70%/human insulin 30% therapy as unknown.The initial reporting consumer did not provide the relatedness assessment of the events to the device use.Edit 07jan2022: updated medwatch fields for expedited device reporting and added contact log accordingly.No new information added.Edit 12jan2022: corrected suspect device name in device use paragraph in the narrative.Update 13jan2022: additional information received on 11jan2022 from the global product complaint database.Entered the device specific safety summary (dsss); updated the medwatch and european and canadian (eu/ca) device fields; and added humapen unknown type not returned to manufacturer which is associated with (b)(4).Added complaint description in narrative.Corresponding fields and narrative updated accordingly.
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Manufacturer Narrative
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No further follow-up is planned.B.5.Narrative field: new, updated, and corrected information is referenced within the update statements in b.5.Please refer to update statement(s) dated 13jan2022 in the b.5.Field.Evaluation summary: a patient reported that they accidently dropped and broke their humapen (unspecified device type).The patient experienced increased blood glucose.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.All humapen devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality with high probability.In addition, all humapen devices have been shown to be compliant with free fall testing requirements of iso 11608-1 "needle based injection systems for medical use." the humapen core instructions for use states to always carry a spare insulin pen in case your pen is lost or damaged.There is no evidence of improper use or storage.
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Search Alerts/Recalls
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