Model Number MS9557 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hyperglycemia (1905); No Code Available (3191)
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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.A follow-up report will be submitted when the final evaluation is completed as necessary.
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Event Description
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(b)(4).This spontaneous case, reported by a consumer who contacted the company to report adverse events and a product complaint, concerned a male patient of an unknown age and origin.Medical history, drug adverse reaction and family drug adverse reaction were unknown.Concomitant medications were not reported.The patient received an unspecified human insulin (rdna origin) (humulin 3 ml:300 iu) from a cartridge via an unknown humapen device, for the treatment of diabetes mellitus and beginning on an unknown date.Dose, units, frequency and route of administration were not provided.Since an unspecified date, while on human insulin therapy, he was experiencing high blood glucose many times and also had uncomfortable heart.Sometimes he was hospitalized because of high blood glucose and uncomfortable heart (dates not provided).On an unknown date, during hospitalization, he was checked out with high blood lipid.He was last hospitalized on (b)(6) 2017 due to high blood glucose.The information regarding any corrective treatment, further hospitalization dates and details and outcome of the events was not provided.Human insulin therapy was ongoing.The operator of humapen unknown device and his/her training status were not provided.The general humapen (unknown device) duration of use and the suspect humapen duration of use were not provided.Action taken with the suspect humapen was not provided and its return status was unknown.The initial reporting consumer did not know if the events were related to human insulin (unknown formulation) therapy or humapen unknown device.Edit 24may2018: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting on 10may2018.No new information added.
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Event Description
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Lilly case id: (b)(4).This spontaneous case, reported by a consumer who contacted the company to report adverse events and a product complaint, concerned a male patient of an unknown age and origin.Medical history, drug adverse reaction and family drug adverse reaction were unknown.Concomitant medications were not reported.The patient received an unspecified human insulin (rdna origin) (humulin 3 ml:300 iu) from a cartridge via a humapen ergo ii device, for the treatment of diabetes mellitus and beginning on an unknown date.Dose, units, frequency and route of administration were not provided.Since an unspecified date, while on human insulin therapy, he was experiencing high blood glucose many times and also had uncomfortable heart.Sometimes he was hospitalized because of high blood glucose and uncomfortable heart (dates not provided).On an unknown date, during hospitalization, he was checked out with high blood lipid.He was last hospitalized on (b)(6) 2017 due to high blood glucose.It was noted that the humapen ergo ii was cracked after reportedly being ground by car (product complaint (b)(4).Lot number 1208d02).The information regarding any corrective treatment, further hospitalization dates and details and outcome of the events was not provided.Human insulin therapy was ongoing.The operator of humapen ergo ii and his/her training status were not provided.The general humapen ergo ii duration of use and the suspect humapen ergo ii duration of use were not provided.The humapen ergo ii was returned to the manufacturer on 11may2018.The initial reporting consumer did not know if the events were related to human insulin (unknown formulation) therapy or humapen ergo ii device.Edit 24may2018: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting on 10may2018.No new information added.Update 03jul2018: additional information received on 03jul2018 from the global product complaint database.Recoded the humapen unknown to a humapen ergo ii.Entered the device specific safety summary (dsss).Updated the medwatch and european and canadian (eu/ca) device fields, improper use and storage from no to yes, malfunction from unknown to yes (not cirm), and device return status to returned to manufacturer.Added the lot number, date of manufacturer and date returned to manufacturer for the suspect device associated with (b)(4).Corresponding fields and narrative updated accordingly.
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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 statement dated 20jul2018 in the b.5.Field.No further follow up is planned.Evaluation summary: a male patient reported that his humapen ergo ii device was broken after being dropped.He also reported that on 03-may-2018 the cartridge holder was "cracked after grind by car." the patient reported being hospitalized many times due to high blood sugar, the most recent time in september 2017.The patient experienced increased blood glucose.The investigation of the returned device (batch 1208d02, manufactured august 2012) found the device was too damaged to test, including damage to the cartridge holder thread ends, a cracked lens, and a missing injection foot.Malfunction confirmed.The damage occurred in the field and is consistent with the patient's description of dropping the device and "grind by car." there is evidence of improper use.The device was damaged while in the field.It is unknown if the damage is relevant to the event of increased blood glucose since the timing of the device being dropped is unknown.
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Search Alerts/Recalls
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