(b)(4).This spontaneous case device only, reported by a consumer who contacted the company to report adverse events concerns a male patient of unspecified age and origin.Medical history and concomitant medications were not provided.The patient received unspecified insulin via a reusable pen humapen savvio blue.The generic name, type of insulin, formulation, indication for use and the start date of therapy were not provided.On an unspecified date in (b)(6) 2017 due to a pen issue, the pen could not deliver the correct amount of medication and due to this, he started to feel bad and weak.On an unspecified date in (b)(6) 2017, his blood glucose level was high (values or units not provided) so he was hospitalized on an unspecified date in (b)(6) 2017 for two or three days.((b)(4); lot 1309v05).Information regarding hospitalization including start and discharge date and corrective treatment was not provided.It was reported that he was fully recovered from the events and he received on (b)(6) 2017 a new humapen savvio.Unspecified insulin status was not provided.The patient was the operator of the humapen savvio and his training status was not provided.The humapen savvio model and reported humapen savvio durations of use were not provided.The device was discontinued.The reporting consumer assessed the events as related to humapen savvio and unspecified insulin.Update 21apr2017: updated medwatch and european and canadian (eu/ca) fields.
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(b)(4).This spontaneous case device only, reported by a consumer who contacted the company to report adverse events, and with additional information from the initial reporter, concerned an approximately (b)(6) (at the time of the report) male patient of unspecified origin.Medical history and concomitant medications were not provided.The patient received unspecified insulin via a reusable pen humapen savvio blue.The generic name, type of insulin, formulation, indication for use and the start date of treatment were not provided.On an unspecified date in (b)(6) 2017, due to a pen issue, the pen could not deliver the correct amount of medication since the dose knob was blocked and due to this, he started to feel bad and weak (associated (b)(4) / lot number 1309v05).He tried to fix the dose knob with the help of a wooden spoon, however, it may be was possible that then too much insulin was released.On an unspecified date in (b)(6) 2017, his blood glucose level was high (results, reference values or units were not provided) and his wife had found him in an unconscious states, so he was hospitalized on an unspecified date in (b)(6) 2017 for two or three days.At hospital, he received an readjusted dose of unspecified insulin from 8-11 units to 6-8 units as a corrective treatment.Information regarding hospitalization including start and discharge date and additional corrective treatments was not provided.It was reported that he felt very well and was fully recovered from the events and he received on (b)(6) 2017 a new humapen savvio.Unspecified insulin status was not provided.The patient was the operator of the humapen savvio and his training status was not provided.The humapen savvio model and reported humapen savvio durations of use were not provided.The device was returned to the manufacturer on (b)(6) 2017.The reporting consumer assessed the events as related to humapen savvio and to the unspecified insulin.Update 21apr2017: updated medwatch and european and canadian (eu/ca) fields.Update 01jun2017: additional information received on 30may2017 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields with device information, the european and canadian (eu/ca) device information, malfunction from unknown to no, and device return status to returned to manufacturer.Added date of manufacturer and date returned to manufacturer for the device.Corresponding fields and narrative updated accordingly.Update 22-jun-2017: additional information was received from the initial reporter on 21-jun-2017.Added the serious event of unconscious, patient demographics (year of birth and age) and a treatment medication.Updated narrative with new information.Edit 22-jun-2017: narrative was corrected in order to improve its readability.No additional changes were made to the case.
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