New, updated, and corrected information is referenced within the update statements.Please refer to update statement dated 17dec2020.No further follow-up is planned.Evaluation summary: a female patient's family reported that, around (b)(6) 2020, the injection button of the patient's humapen (unspecified device type) could not be pressed down sometimes and could not be injected.They also reported that a cartridge of insulin could be used for around 15 days previously, but then a cartridge could only be used for around seven days, hence the device was inaccurate; the device sometimes injected more, sometimes injected less or sometimes did not inject.The patient experienced increased blood glucose and decreased blood glucose.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 devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality and dose accuracy with high probability.The patient indicated the device was obtained in 2006 and used for around 14 years.The humapen user manuals indicate the timeframe for which a device model has been designed to be used.Fourteen years exceeds the timeframe for any humapen model.There is evidence of improper use.The patient used the device beyond its approved use life.It is unknown if this is relevant to the event of increased and decreased blood glucose levels.
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Lilly case id: (b)(4).This report is associated with product complaint: (b)(4).This spontaneous case, reported by consumer who contacted the company to report adverse events and product complaint (pc), concerned a 70 years old female patient of han nationality.Medical history and family drug adverse reaction were none.Previous drug adverse reaction was not provided.Concomitant medication included antihypertensive drugs and traditional chinese medicine for unknown indication.The patient received insulin lispro protamine suspension 50%/insulin lispro 50% (rdna origin) injections (humalog mix 50, 100u/ml) from cartridge via humapen unknown device (reported as gray plastic but also reported based on product color information that was provided it could not specifically match any humapen sold in china market), twice a day at unknown dose, subcutaneously, for the treatment of diabetes mellitus, from around 2015.Since an unknown date in 2018, after starting insulin lispro protamine suspension 50%/insulin lispro 50% therapy, her left and right ears were also a little inaudible and inaudible, respectively.On an unknown date, she had discomfort, unstable blood pressure, sometimes high and sometimes low blood glucose, high blood glucose before meals and post meals, and was hospitalized for regulating blood glucose (no further information regarding hospitalisation was provided).She did not dare to eat, and only ate a little.The blood glucose rose immediately after eating, and the uric acid was also inaccurate.No values and reference ranges were provided for the laboratory tests.In around (b)(6) 2020, the injection button of the humapen (unknown device) was not good to be pressed, could not be pressed down sometimes and could not be injected.It was also reported that a cartridge of insulin lispro protamine suspension 50%/insulin lispro 50% could be used for around 15 days previously, but then a cartridge could only be used for around seven days, hence the humapen (unknown device) was inaccurate.As a result, humapen (unknown device) was sometimes injecting more, sometimes injecting less or sometimes could not inject ((b)(4)/ lot number unknown).She did not treat inaudible while information regarding corrective treatment of the remaining events and outcome for the events was not provided.Insulin lispro protamine suspension 50%/insulin lispro 50% was ongoing.The operator of the humapen (unknown device) and his/her training status were not provided.The humapen (unknown device) model duration of use was not provided.The suspect humapen (unknown device) duration of use was around 14years, (it was considered as improper use of device) as it was started in 2006.The use of the humapen (unknown device) was ongoing.The suspect humapen (unknown device) associated with product complaint (b)(4) was not returned to the manufacturer.The reporting consumer related the events to insulin lispro protamine suspension 50%/insulin lispro 50% therapy.The reporting consumer related the events of blood glucose (high and low), wrong dose administered and missed dose with the humapen (unknown device) issue and did not provide a relatedness assessment for the remaining events to humapen (unknown device).Update 17-dec-2020: additional information was received from the initial reporter on 14-dec-2020 via psp.Updated treatment received of event inaudible.Updated the narrative and causality statement with new information.Update 17dec2020: additional information received on 17dec2020 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields with device information and the european and canadian (eu/ca) device information for the suspect humapen (unknown device), which was not returned to the manufacturer.Corresponding fields and narrative updated accordingly.
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