New, updated and corrected information is referenced within the update statements in describe event or problem.No further follow-up is planned.Evaluation summary: a male patient reported that on an unknown date he dropped his humapen savvio device on the floor and the cartridge holder broke.The patient experienced diabetic coma on an unknown date.It is unclear if the cartridge holder break and the diabetic coma event are related.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.There is no evidence of improper use or storage.
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(b)(4).This spontaneous case, reported by a consumer, who contacted the company to report a product complaint and adverse events, concerns a male patient of unknown age and ethnicity.Medical history and concomitant medications were not provided.The patient received human insulin (rdna origin) 30% regular, 70% nph (humulin 70n/30r) cartridge, unknown dose, route, frequency and indication, since unspecified date prior to 2007.On unknown date, unspecified time prior or after beginning treatment with human insulin 30% regular, 70% nph via humapen savvio graphite 3 ml, the patient experienced prediabetic coma (as reported), which was considered serious due to medically significant reasons by the company.Information regarding laboratorial exams, corrective treatment and outcome was not provided.In (b)(6) 2017, unspecified time after beginning treatment with human insulin 30% regular, 70% nph via humapen savvio graphite 3 ml, patient experienced a generalized infection, and for this reason, he was hospitalized in intensive care unit (icu).Information regarding laboratorial exams, corrective treatment, duration of hospitalization and discharge date was not provided.The patient recovered from generalized infection.On unspecified date, reported on (b)(6) 2017 as recently, patient experienced three falls when he was getting up to answer phone calls.Information about corrective treatment and outcome was not provided.On unknown date, patient dropped his humapen savvio on the floor and the cartridge holder broke ((b)(4)/lot unknown).Treatment status with human insulin 30% regular, 70% nph was not provided.Follow up could not be obtained as the reporter refused further contact.It was unknown who operated the device and if the operator was trained.The device model and the reported device had been used for unspecified time.The suspect device was not returned to the manufacturer.The reporting consumer did not provide any relatedness opinion.Update 05sep2017: additional information received on 05sep2017 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch/european and canadian (eu/ca) device information and device return status to not returned to manufacturer for the pc 4102132 associated with the humapen savvio (graphite) device.Corresponding fields and narrative updated accordingly.Update 19sep2017: updated medwatch fields for expedited device reporting.No new information added.
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