Model Number MS9557 |
Device Problem
Mechanical Problem (1384)
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Patient Problem
Hyperglycemia (1905)
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Event Date 01/31/2012 |
Event Type
Injury
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Manufacturer Narrative
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Since the device is not being returned, evaluation for a malfunction is not possible.This is an initial report.A follow-up report will be submitted when the final evaluation is completed.This report is associated with 1819470-2019-00066 since there is more than one device implicated.
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Event Description
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Lilly case id: (b)(4).This report is associated with product compliant: (b)(4).This spontaneous case, reported by a consumer who contacted the company to report adverse events and product complaint (pc), female patient of unknown age and orgin.Medical history was not provided.Concomitant medications included ongoing acarbose for the treatment of diabetes mellitus.The patient received human insulin isophane suspension 70%/human insulin 30% rdna origin) (humulin 70/30) via cartridge through reusable humapen ergo ii, 42 units at morning and 24 at evening subcutaneously, twice daily for the treatment of diabetes mellitus, beginning on an unknown date.On an unknown date, her two humapens had a situation that the screw rod could not be pushed out (specific time of onset unknown).In 2012, while on human insulin isophane suspension 70%/human insulin 30%, she had experienced hyperglycemia.Her blood sugar value was 19 (no units provided).She was hospitalized due to hyperglycemia.On an unknown date, she was discharged.On an unknown date, during human insulin 70/30 treatment, according to her blood sugar condition she changed her dose from 36 units at morning and 24 units at evening (the doctor advice) to 42 units at morning and 21 units at evening by herself.Information regarding corrective treatment and outcome of remaining event was not provided.Outcome of event hyperglycemia was recovering.Human insulin isophane suspension 70%/human insulin 30% was continued.Follow up would not be possible as reporter refused to accept the follow-up via phone and treating physician contact details was not provided.The patient was operator of humapens ergo ii and her training status was unknown.The humapen ergo ii model duration of use started in 2009.The suspect humapens ergo ii duration of use were not provided.The action taken with the devices was unknown and their return was not expected.The reporting consumer was not sure about any relatedness between event of hyperglycemia and human insulin 70/30 and did not provide the relatedness between remaining event and human insulin 70/30 and did not provide the relatedness between events and humapens ergo ii.Update 01-apr-2019: initial information received on 28-mar-2019 and follow-up information received on 01-apr-2019 were processed together.Edit 16apr2019: updated medwatch and european and (b)(4) (eu/(b)(4)) fields for expedited device reporting.No new information added.
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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 30apr2019 in the b.5.Field.No further follow up is planned.This report is associated with 1819470-2019-00066 since there is more than one device implicated.Evaluation summary: a female patient reported that the injection screw of her humapen ergo ii device "could not move out due to it move out slowly" and the cartridge holder was cracked.She experienced hyperglycemia.The device was not returned for investigation (batch unknown).The patient changed to a new needle, primed the pen, and the issue resolved.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 core instructions for use states if any of the parts of your humapen ergo ii appear broken or damaged, do not use.There is evidence of improper use.The patient continued to use the device with a cracked cartridge holder.This may not have been relevant to the complaint as the pen functioned normally after the needle was changed.
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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 product complaint (pc), female patient of unknown age and origin.Medical history was not provided.Concomitant medications included ongoing acarbose for the treatment of diabetes mellitus.The patient received human insulin isophane suspension 70%/human insulin 30% rdna origin) (humulin 70/30) via cartridge through reusable humapen ergo ii, 42 units at morning and 24 at evening subcutaneously, twice daily for the treatment of diabetes mellitus, beginning on an unknown date.On an unknown date, her two humapens had a situation that the screw rod could not be pushed out (specific time of onset unknown).The operator believed that spiral rod of devices did not move because the spiral rod came out slowly ((b)(4), lot -unknown, (b)(4), lot no.-unknown).In 2012, while on human insulin isophane suspension 70%/human insulin 30%, she had experienced hyperglycemia.Her blood sugar value was 19 (no units provided).She was hospitalized due to hyperglycemia.On an unknown date, she was discharged.On an unknown date, during human insulin 70/30 treatment, according to her blood sugar condition she changed her dose from 36 units at morning and 24 units at evening (the doctor advice) to 42 units at morning and 21 units at evening by herself.Information regarding corrective treatment and outcome of remaining event was not provided.Outcome of event hyperglycemia was recovering.Human insulin isophane suspension 70%/human insulin 30% was continued.Follow up would not be possible as reporter refused to accept the follow-up via phone and treating physician contact details was not provided.The patient was operator of humapens ergo ii and her training status was unknown.The humapen ergo ii model duration of use started in 2009.The suspect humapens ergo ii duration of use were not provided.The action taken with the devices was unknown and they were not returned to the manufacturer.The reporting consumer was not sure about any relatedness between event of hyperglycemia and human insulin 70/30 and did not provide the relatedness between remaining event and human insulin 70/30 and did not provide the relatedness between events and humapens ergo ii.Update 01-apr-2019: initial information received on 28-mar-2019 and follow-up information received on 01-apr-2019 were processed together.Edit 16apr2019: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Edit 22-apr-2019: upon review of information received on 28-mar-2019 and 01-apr-2019.Updated product complaint descriptions and pc citations in the narrative.No other changes were made to case.Update 30apr2019: additional information received on 30apr2019 from the global product complaint database.Entered the device specific safety summary (dsss) and updated the medwatch and european and canadian (eu/ca) device fields for the suspect humapen ergo ii device associated with (b)(4).Entered the device specific safety summary (dsss) and updated the medwatch and european and canadian (eu/ca) device fields, improper use and storage from no to yes, and malfunction from unknown to no for the suspect humapen ergo ii device associated with (b)(4).Corresponding fields and narrative updated accordingly.
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