Model Number MS9557 |
Device Problems
Mechanical Jam (2983); Mechanics Altered (2984)
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Patient Problem
Hyperglycemia (1905)
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Event Type
Injury
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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 solicited case, reported by a consumer via a patient support program (psp), concerns a 65-year-old (at time of initial report) male patient of han nationality.Medical history included hospitalization in 2019.Complicating disease, allergic history, family medical history, family allergic history, previous drug adverse reaction, family drug reaction and concomitant medications were none.The patient received insulin lispro protamine suspension 50%/insulin lispro 50% (rdna origin) (humalog mix50) from a cartridge via a reusable device (humapen ergo ii), 20 units in the morning and 12 units at night, two times a day (bid), subcutaneously, for the treatment of type two diabetes mellitus, beginning in 2019.On an unknown date, after starting insulin lispro protamine suspension 50%/insulin lispro 50% therapy, he had high fasting blood glucose every morning.Approximately since apr-2022, the fasting blood glucose value was 10-20 (units and reference range not provided).His blood glucose originally was not that high.On an unspecified date, one of his humapen ergo ii devices were difficult to press when injecting (pc number (b)(4), lot number 180501ce, as reported).He changed the needle before each injection, and the needle had not been bent or jammed, at normal times he pressed the middle part of the injection button when injection, and he pressed softly.He stored the pen with the needle attached at ordinary times (this was considered as improper use of the device).In may-2022, his blood glucose was pretty high at around 13-14 and 14-15 due to which he was hospitalized as his blood glucose had not dropped all the time.After hospitalization, he was conditioning his blood glucose.Further information regarding hospitalization, corrective treatment, discharge date and outcome of the events was not provided.Status of insulin lispro protamine suspension 50%/insulin lispro 50% therapy was ongoing.The patient was the operator of huma pen ergo ii and his training status was not provided.The humapen ergo ii model duration of use was not provided.The suspect humapen ergo ii device duration of use was around 3years since it was started in 2019.The action taken with suspect humapen ergo ii device and its return was unknown.The reporting consumer did not provide if the events reported were related to insulin lispro protamine suspension 50%/insulin lispro 50% drug or with suspect humapen ergo ii device.Update 17-may-2022: additional information was received from the initial reporting consumer via psp on 13-may-2022.This case was upgraded due to addition of one serious event of blood glucose increased, requiring hospitalization.Added one lab test of blood glucose.Added partial therapy start date and updated formulation as cartridge for humalog mix50.Added a suspect device of humapen ergo ii with provided lot number.Updated causality statement and accordingly updated narrative with new information.Edit 19may2022: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.
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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 solicited case, reported by a consumer via a patient support program (psp), concerns a 65-year-old (at time of initial report) male patient of han nationality.Medical history included hospitalization in 2019.Complicating disease, allergic history, family medical history, family allergic history, previous drug adverse reaction, family drug reaction and concomitant medications were none.The patient received insulin lispro protamine suspension 50%/insulin lispro 50% (rdna origin) (humalog mix50) from a cartridge via a reusable device (humapen ergo ii), 20 units in the morning and 12 units at night, two times a day (bid), subcutaneously, for the treatment of type two diabetes mellitus, beginning in 2019.On an unknown date, after starting insulin lispro protamine suspension 50%/insulin lispro 50% therapy, he had high fasting blood glucose every morning.Approximately since (b)(6) 2022, the fasting blood glucose value was 10-20 (units and reference range not provided).His blood glucose originally was not that high.On an unspecified date, one of his humapen ergo ii devices were difficult to press when injecting (pc number (b)(4), lot number 180501ce, as reported).He changed the needle before each injection, and the needle had not been bent or jammed, at normal times he pressed the middle part of the injection button when injection, and he pressed softly.He stored the pen with the needle attached at ordinary times (this was considered as improper use of the device).In (b)(6) 2022, his blood glucose was pretty high at around 13-14 and 14-15 due to which he was hospitalized as his blood glucose had not dropped all the time.After hospitalization, he was conditioning his blood glucose.Further information regarding hospitalization, corrective treatment, discharge date and outcome of the events was not provided.Status of insulin lispro protamine suspension 50%/insulin lispro 50% therapy was ongoing.The patient was the operator of huma pen ergo ii and his training status was not provided.The humapen ergo ii model duration of use was not provided.The suspect humapen ergo ii device duration of use was around 3years since it was started in 2019.The action taken with suspect humapen ergo ii device and was not returned to the manufacturer for investigation.The reporting consumer did not provide if the events reported were related to insulin lispro protamine suspension 50%/insulin lispro 50% drug or with suspect humapen ergo ii device.Update 17-may-2022: additional information was received from the initial reporting consumer via psp on (b)(6) 2022.This case was upgraded due to addition of one serious event of blood glucose increased, requiring hospitalization.Added one lab test of blood glucose.Added partial therapy start date and updated formulation as cartridge for humalog mix50.Added a suspect device of humapen ergo ii with provided lot number.Updated causality statement and accordingly updated narrative with new information.Edit 19may2022: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 27may2022: additional information received on 25may2022 from the global product complaint database.Entered device specific safety summary (dsss) for humapen ergo ii device associated with (b)(4), lot 180501ce.Updated the medwatch fields/ european and canadian (eu/ca) device information and device return status to not returned to manufacturer.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 update statement dated 27may2022 in the b.5.Field.No further follow-up is planned.Evaluation summary: a male patient reported that his humapen ergo ii device was difficult to press when injecting.The patient experienced increased blood glucose.The device was not returned to the manufacturer for investigation (reported batch number 180501ce, which is not a valid batch number).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.While the reported batch number 180501ce is not a valid batch number, the batch number 1805d01, sold in the case country china, is likely the batch number of the patient's device.A complaint history review of batch 1805d01 did not identify any atypical findings with regard to injection force high or dose accuracy issues.All humapen ergo ii devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality with high probability.The patient stored the pen with the needle attached.The core instructions for use state to not store the pen with the needle attached.There is evidence of improper storage.The patient stored the pen with the needle attached.It is unknown if this misuse is relevant to the complaint or the event of increased blood glucose.
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Search Alerts/Recalls
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