Model Number MS9557 |
Device Problems
Insufficient Flow or Under Infusion (2182); Mechanical Jam (2983); Insufficient Information (3190)
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Patient Problem
Hyperglycemia (1905)
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Event Date 03/31/2023 |
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 spontaneous case, reported by a consumer who contacted the company to report adverse events and product complaint (pc), concerns a 12-years-old (at the time of initial report) male patient of an unknown origin.Medical history included diabetes since 2016.Concomitant medications were not provided.The patient received insulin lispro (rdna origin) (humalog r, 100 units/ml) from a cartridge via a reusable device (humapen ergo ii), 16 international units (iu), three times a day (tid), subcutaneously, for the treatment of diabetes, beginning on an unknown date.He also received insulin glargine (lantus) unknown formulation, at an unknown dose, frequency, route, for diabetes, beginning on an unknown date.His parents stored the insulin glargine (lantus) pen attached to cartridge in its package at room temperature however physician advised to store the cartridge in the refrigerator.On an unknown date, an insulin lispro cartridge broke inside the pen.Since an unspecified date, the humapen ergo ii was stuck and rotate on loss while using ((b)(4), lot 1806d03).On an unknown date in (b)(6) 2023, he experienced diabetic peripheral angiopathy (dpa) due to which he was hospitalized.The physician assessed two possible reasons for dpa, first that the insulin glargine (lantus) got deteriorated due to inappropriate way of storage or second reason may be incomplete dose administered due to humapen ergo ii device issue.Further information regarding hospitalization and corrective treatment was not provided.Outcome of the events was recovered.Status of insulin lispro therapy was ongoing and status of insulin glargine (lantus) treatment was not provided.The operator of huma pen ergo ii were the parents of the patient and their training status was not provided.The general and suspect humapen ergo ii device duration of use was not reported.The status of suspect device was available, and its return was expected.The reporting consumer did not relate the events to the insulin lispro drug but related to the suspect humapen ergo ii device.The reporting consumer did not provide any relatedness between the events and insulin glargine (lantus) therapy.Update 26-mar-2023: information was received on 22-mar-2023 from the affiliate provided the product complaint reference number ((b)(4)).No new medically significant information was received, no changes were made to the case.Update 29-mar-2023: information was received from affiliate on 28-mar-2023.No hcp details provided.No new medically significant information provided, no changes were made to the case.Edit 04apr2023: updated medwatch 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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Manufacturer Narrative
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No further follow-up is planned.B.5.Narrative field: new, updated, and corrected information is referenced within the update statements in b.5.Please refer to update statement(s) dated 26apr2023 in the b.5.Field.Evaluation summary a consumer reported on behalf of male patient that his humapen ergo ii device "was stuck and rotate on loss while using." his physician assessed that there "may be incomplete dose administered due to humapen ergo ii device issue." the patient experienced diabetic vascular disorder.The device was not returned to the manufacturer for investigation (batch 1806d03, manufactured june 2018).Malfunction unknown.A batch complaint threshold review of the dose accuracy issue determined the total number of dose accuracy complaints received for the batch is within the established batch threshold.A batch record review and safety case review of the batch did not identify any atypical findings.All humapen ergo ii 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 reported changing needles every two days (every six doses based on frequency of use).The core instructions for use state to use a new needle for each injection.There is evidence of improper use.The patient reused needles.This misuse may be relevant to the complaint.It is unknown if this misuse is relevant to the event of diabetic vascular disorder.
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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 spontaneous case, reported by a consumer who contacted the company to report adverse events and product complaint (pc), concerns a 12-years-old (at the time of initial report) male patient of an unknown origin.Medical history included diabetes since 2016.Concomitant medications were not provided.The patient received insulin lispro (rdna origin) (humalog r, 100 units/ml) from a cartridge via a reusable device (humapen ergo ii), 16 international units (iu), three times a day (tid), subcutaneously, for the treatment of diabetes, beginning on an unknown date.He also received insulin glargine (lantus) unknown formulation, at an unknown dose, frequency, route, for diabetes, beginning on an unknown date.His parents stored the insulin glargine (lantus) pen attached to cartridge in its package at room temperature however physician advised to store the cartridge in the refrigerator.On an unknown date, an insulin lispro cartridge broke inside the pen.Since an unspecified date, the humapen ergo ii was stuck and rotate on loss while using ((b)(4), lot 1806d03).On an unknown date in mar-2023, he experienced diabetic peripheral angiopathy (dpa) due to which he was hospitalized.The physician assessed two possible reasons for dpa, first that the insulin glargine (lantus) got deteriorated due to inappropriate way of storage or second reason may be incomplete dose administered due to humapen ergo ii device issue.Further information regarding hospitalization and corrective treatment was not provided.Outcome of the events was recovered.Status of insulin lispro therapy was ongoing and status of insulin glargine (lantus) treatment was not provided.The operator of huma pen ergo ii were the parents of the patient and their training status was not provided.The general and suspect humapen ergo ii device duration of use was not reported.The status of suspect device was available, and its return was expected.The reporting consumer did not relate the events to the insulin lispro drug but related to the suspect humapen ergo ii device.The reporting consumer did not provide any relatedness between the events and insulin glargine (lantus) therapy.Update 26-mar-2023: information was received on 22-mar-2023 from the affiliate provided the product complaint reference number ((b)(4)).No new medically significant information was received, no changes were made to the case.Update 29-mar-2023: information was received from affiliate on 28-mar-2023.No hcp details provided.No new medically significant information provided, no changes were made to the case.Edit 04apr2023: updated medwatch fields for expedited device reporting.No new information added.Update 26apr2023: additional information received on 20apr2023 from the global product complaint database.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; and added date of manufacture for the suspect humapen ergo ii associated with pc 6401458.Corresponding fields and narrative updated accordingly.
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Search Alerts/Recalls
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