Model Number MS9557 |
Device Problems
Use of Device Problem (1670); Failure to Deliver (2338)
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Patient Problem
Hyperglycemia (1905)
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Event Date 01/31/2021 |
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.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: pending.This solicited case, reported by a consumer via a patient support program (psp), concerned a (b)(6) year-old (at the time of initial report) male patient with unknown origin.Medical history and concomitant medications were not provided.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) injections (humulin 70/30), from cartridge via a reusable device humapen ergo ii, at an unknown dose and frequency subcutaneously for the treatment of diabetes, beginning on an unknown date in 2008.On an unknown date in (b)(6) 20201, while on human insulin isophane suspension 70%/human insulin 30% therapy, his humapen ergo ii was impaired as upon pressing, it did not release insulin.He then shifted to take the insulin by syringes but he found difficulty in adjusting the dose by them as he could not read which made his blood glucose reached 600 mg/dl (reference range not provided) and became unstable (pc number: unknown and batch number: 1108d01).The event blood sugar increased was considered as serious due to medical significance reason.Information regarding corrective treatment was not provided.Outcome of the event was not resolved.Human insulin isophane suspension 70%/human insulin 30% therapy was continued.The operator of humapen ergo ii and her training status were not provided.The general humapen ergo ii was not provided and suspect humapen ergo ii duration was approximately 12 years as it was started in 2008.The status of humapen ergo ii was not provided and its return was expected.The initial reporting consumer did not provide the relatedness assessment of the event with human insulin isophane suspension 70%/human insulin 30% therapy and humapen ergo ii.Edit 15jan2021: updated medwatch fields for expedited device reporting.No new information added.
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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), concerned a 70-year-old (at the time of initial report) male patient with unknown origin.Medical history and concomitant medications were not provided.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) injections (humulin 70/30), from cartridge via a reusable device humapen ergo ii, at an unknown dose and frequency subcutaneously for the treatment of diabetes, beginning on an unknown date in 2008.On an unknown date in (b)(6) 20201, while on human insulin isophane suspension 70%/human insulin 30% therapy, his humapen ergo ii was impaired as upon pressing, it did not release insulin.He then shifted to take the insulin by syringes but he found difficulty in adjusting the dose by them as he could not read which made his blood glucose reached 600 mg/dl (reference range not provided) and became unstable (pc number: (b)(4) and batch number: 1108d01).The event blood sugar increased was considered as serious due to medical significance reason.Information regarding corrective treatment was not provided.Outcome of the event was not resolved.Human insulin isophane suspension 70%/human insulin 30% therapy was continued.The operator of humapen ergo ii and her training status were not provided.The general humapen ergo ii was not provided and suspect humapen ergo ii duration was approximately 12 years as it was started in 2008.( conflicting information as date of manufacturer was aug2011).The status of humapen ergo ii was not provided.The suspect humapen ergo ii (lot number 1108d01) relating to product complaint (b)(4) was not returned to the manufacturer.The initial reporting consumer did not provide the relatedness assessment of the event with human insulin isophane suspension 70%/human insulin 30% therapy and humapen ergo ii.Edit 15jan2021: updated medwatch fields for expedited device reporting.No new information added.Edit 17-mar-2021: upon review, pc number added in narrative.No other changes were made to the case.Update 31mar2021: additional information received on 30mar2021 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields with device information and the european and canadian (eu/ca) device information.Added date of manufacturer for the suspect humapen ergo ii (lot number 1108d01) device associated with product complaint 5512537 which was not returned to the manufacturer.Corresponding fields and narrative updated accordingly.
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Manufacturer Narrative
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No further follow-up is planned.Evaluation summary: a male patient reported that his humapen ergo ii was impaired as upon pressing and did not release insulin.He patient experienced increased blood glucose.The device was not returned to the manufacturer for investigation (batch 1108d01, manufactured august 2011).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.A complaint history review and a batch trend review did not identify any atypical findings with regard to device not working 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 reported that he had used the device approximately 12 years; however, the device was manufactured august 2011 (9.5 years ago).The core instructions for use state the humapen ergo ii has been designed to be used for up to 3 years after first use.There is evidence of improper use.The patient used the device beyond the recommended use period.This misuse may be relevant to the complaint or the event of increased blood glucose.
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Search Alerts/Recalls
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