Model Number MS9557 |
Device Problem
Insufficient Information (3190)
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Patient Problem
Glaucoma (1875)
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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.This report is associated with 1819470-2017-00224 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 an adverse events and product complaint (pc), concerned an (b)(6)-year-old (b)(6) female patient.Medical history included hypertension.She had no previous drug reaction and no family history of drug reaction.She did not receive any concomitant medication.The patient received insulin lispro (rdna origin) injections (humalog 100u/ml) via a cartridge through a reusable humapen ergo ii device, 15 units three times daily subcutaneously for the treatment of diabetes mellitus beginning in 2007.While using this humapen, it had malfunction.While on insulin lispro treatment, she was hospitalized many times, for unspecified reasons.On an unspecified date in (b)(6) 2017, she stopped using the first humapen ergo ii she started using another humapen ergo ii and she was hospitalized due to unstable blood glucose (no values provided) and glaucoma which were diabetic complications.(pc: 4205229, lot number 1609d01/pc: 4205230, lot number unknown).Further details regarding the hospitalization were not provided.Information regarding corrective treatment and outcome of events was not provided.Insulin lispro treatment was continued.The operator of humapen ergo ii and his/her training status was unknown.The humapen ergo ii model duration of use started in 2007.The suspect humapen ergo ii devices duration of use was not provided.The action taken with the suspect humapen ergo ii devices was not provided and their return was not expected.The reporting consumer did not provide the relatedness between events and insulin lispro treatment or between events and humapen ergo ii devices.Update (b)(6) 2017: this case was determined to be non-valid as there was no identifiable event.Update (b)(6) 2017: additional information received on (b)(6) 2017 from initial reporter.Added two serious events of blood glucose abnormal and glaucoma which validated the case.Added lab data.Updated concomitant devices to suspect devices, re-processed pcs, causality statement and narrative accordingly.Edit (b)(6) 2018: updated medwatch and european and (b)(6) (eu/(b)(6)) fields for expedited device reporting on both suspect devices.No new information added.Edit (b)(6) 2018: updated manufacturer report number on the medwatch fields for each suspect device.
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Manufacturer Narrative
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Narrative field: new, updated and corrected information is referenced within the update statements.Please refer to update statement dated 10jan2018.No further follow-up is planned.This report is associated with 1819470-2017-00224 since there is more than one device implicated.Evaluation summary: a female patient reported her humapen ergo ii device had a malfunction.She experienced abnormal blood glucose.The device was not returned to the manufacturer for investigation (batch number unknown).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.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.There is no evidence of improper use.
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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 an adverse events and product complaint (pc), concerned an (b)(6)-year-old asian female patient.Medical history included hypertension.She had no previous drug reaction and no family history of drug reaction.She did not receive any concomitant medication.The patient received insulin lispro (rdna origin) injections (humalog 100u/ml) via a cartridge through a reusable humapen ergo ii device, 15 units three times daily subcutaneously for the treatment of diabetes mellitus beginning in 2007.While on insulin lispro treatment via humapen ergo device, she was hospitalized many times, for unspecified reasons and on unspecified dates; details and date not provided.On an unspecified date in (b)(6)-2017, she stopped using the first humapen ergo ii which was noted to not work (pc: (b)(4), lot number unknown).She started using another humapen ergo ii pen which was noted to have jammed further described that the injection button could not be pushed down (pc: (b)(4), lot number 1609d01).The needle was changed before every injection.She was hospitalized due to unstable blood glucose (no values provided) and glaucoma which were diabetic complications.Further details regarding the hospitalization were not provided.Information regarding corrective treatment and outcome of events was not provided.Insulin lispro treatment was continued.The operator of humapen ergo ii devices and his/her training status was unknown.The humapen ergo ii model duration of use started in 2007.The suspect humapen ergo ii devices duration of use were not known.The suspect device with pc (b)(4), which was manufactured in sep2016, was not returned to the manufacturer; other suspect device with pc (b)(4) also was not returned to the manufacturer.The reporting consumer did not provide the relatedness between events and insulin lispro treatment or between events and humapen ergo ii devices.Update 07-dec-2017: this case was determined to be non-valid as there was no identifiable event.Update 14-dec-2017: additional information received on 11-dec-2017 from initial reporter.Added two serious events of blood glucose abnormal and glaucoma which validated the case.Added lab data.Updated concomitant devices to suspect devices, re-processed pcs, causality statement and narrative accordingly.Edit 05jan2018: updated medwatch and european and (b)(6) fields for expedited device reporting on both suspect devices.No new information added.Edit 05jan2018: updated manufacturer report number on the medwatch fields for each suspect device.Update 10jan2017: additional information received on 09jan2018 from the global product complaint database.Entered device specific safety summaries (dsss).Updated the medwatch/european and (b)(6) device information and device return status to not returned to manufacturer for (b)(4) of humapen ergo ii devices.Added date of manufacturer for (b)(4) associated with lot 1609d01 for humapen ergo ii device.Corresponding fields and narrative updated accordingly.
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Search Alerts/Recalls
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