Model Number MS8929 |
Device Problems
Break (1069); Connection Problem (2900)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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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.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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(b)(4).This spontaneous case, reported by a consumer who contacted the company to report an adverse event and a product complaint (pc), concerned a male patient of unknown age and origin.Medical history and concomitant medications were not reported.The patient received insulin lispro (rdna origin) injection (humalog) via reusable pen (humapen unknown body type) 8 (no units) each morning, 6 (no units) each noon and 6 (no units) at night daily, subcutaneously for the treatment of diabetes mellitus beginning on (b)(6) 2015.Sometime while on treatment, he injected and adjusted dose of insulin lispro not according to what his treating physician prescribed.In (b)(6) 2016, the humapen unknown body type broke down ((b)(4)/lot unknown), and was replaced with a humapen ergo teal with a clear cartridge holder.In either (b)(6) 2016, he began having problems with the humapen ergo.The cartridge holder of the humapen ergo could not connect tightly to the body of the pen ((b)(4)/lot 0402a02).On (b)(6) 2017, while using insulin lispro via the humapen ergo, he was hospitalized to have blood glucose adjust.Further hospitalization details were not provided.Information regarding corrective treatment and outcome of the events were not provided.Insulin lispro was continued.The patient was the operator of the humapen ergo and his training status was not provided.The humapen ergo model duration and suspect humapen ergo model duration of use was approximately four months.The status of the humapen ergo device was unknown.The reporting consumer did not know if the events were related to insulin lispro treatment or humapen ergo device.The reporter refused to be contacted and did not give permission to contact the treating physician.Update 01-mar-2017: upon review, the case was opened to update the medwatch fields for regulatory reporting.Update 02-mar-2017: additional information received on 24-feb-2017 from the product complaint database added the (b)(4); added the product complaint information along with the time line for device use; updated the humapen ergo from an unknown body type to a humapen ergo teal with a clear cartridge holder; and updated the narrative.Update 07-mar-2017:on 28-feb-2017, two product complaint numbers associated with this case were received; however, the information had previously been entered in the case.No changes made to this case.
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Manufacturer Narrative
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No further follow up is planned.Evaluation summary: a male patient reported that the cartridge holder of his humapen ergo device could not connect tightly to the body of the pen.He experienced abnormal blood glucose.The device was not returned to the manufacturer for investigation (batch 0402a02, manufactured february 2004).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.A complaint history review of the batch did not identify any atypical findings with regard to dose accuracy or cartridge holder attachment issues.The device was provided to the patient 12 years beyond manufacture date.It is unknown if is this is relevant to the event of abnormal blood glucose.There is no evidence of improper use or storage.
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Event Description
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Lilly case id: (b)(6).This spontaneous case, reported by a consumer who contacted the company to report an adverse event and a product complaint (pc), concerned a male patient of unknown age and origin.Medical history and concomitant medications were not reported.The patient received insulin lispro (rdna origin) injection (humalog) via reusable pen (humapen unknown body type) 8 (no units) each morning, 6 (no units) each noon and 6 (no units) at night daily, subcutaneously for the treatment of diabetes mellitus beginning on (b)(6) 2015.Sometime while on treatment, he injected and adjusted dose of insulin lispro not according to what his treating physician prescribed.In (b)(6) 2016, the humapen unknown body type broke down (product complaint 3920218/lot unknown), and was replaced with a humapen ergo teal with a clear cartridge holder.In either (b)(6) 2016, he began having problems with the humapen ergo.The cartridge holder of the humapen ergo could not connect tightly to the body of the pen (product complaint 3920221/lot 0402a02).On (b)(6) 2017, while using insulin lispro via the humapen ergo, he was hospitalized to have blood glucose adjust.Further hospitalization details were not provided.Information regarding corrective treatment and outcome of the events were not provided.Insulin lispro was continued.The patient was the operator of the humapen ergo and his training status was not provided.The humapen ergo model duration and suspect humapen ergo model duration of use was approximately four months.The humapen ergo device was not returned to the manufacturer.The reporting consumer did not know if the events were related to insulin lispro treatment or humapen ergo device.The reporter refused to be contacted and did not give permission to contact the treating physician.Update 01-mar-2017: upon review, the case was opened to update the medwatch fields for regulatory reporting.Update 02-mar-2017: additional information received on 24-feb-2017 from the product complaint database added the product complaint numbers 3920218 and 3920221; added the product complaint information along with the time line for device use; updated the humapen ergo from an unknown body type to a humapen ergo teal with a clear cartridge holder; and updated the narrative.Update 07-mar-2017:on 28-feb-2017, two product complaint numbers associated with this case were received; however, the information had previously been entered in the case.No changes made to this case.Update 27mar2017: additional information received on 27mar2017 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields with the humapen ergo teal/clear device information, and the european and canadian (eu/ca) device information for the humapen ergo teal/clear.Added date of manufacturer.Corresponding fields and narrative updated accordingly.
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Manufacturer Narrative
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New updated and corrected information is referenced within the update statements in describe event or problem.No further follow up is planned.Evaluation summary a male patient reported that the cartridge holder of his humapen ergo device could not connect tightly to the body of the pen.He experienced abnormal blood glucose.Investigation of the returned device (batch 0402a02, manufactured february 2004) found that the spring arms on the cartridge holder were broken, however the damaged cartridge holder did securely attach to the body of the device.The device met functional requirements and met dose accuracy and glide (injection) force specifications.No malfunction was identified.The spring arm feature on the cartridge holder provides a normal cartridge holder retention torque.When the spring arms are cracked or broken, the cartridge holder retention torque is reduced.The reduced torque may account for the patient's perception of a loose connection.The device was provided to the patient by a hospital 12 years beyond manufacture date.It is unknown if is this is relevant to the event of abnormal blood glucose.There is no evidence of improper use or storage.
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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 event and a product complaint (pc), concerned a male patient of unknown age and origin.Medical history and concomitant medications were not reported.The patient received insulin lispro (rdna origin) injection (humalog) via reusable pen (humapen unknown body type) 8 (no units) each morning, 6 (no units) each noon and 6 (no units) at night daily, subcutaneously for the treatment of diabetes mellitus beginning on (b)(6) 2015.Sometime while on treatment, he injected and adjusted dose of insulin lispro not according to what his treating physician prescribed.In (b)(6) 2016, the humapen unknown body type broke down ((b)(4)/lot unknown), and was replaced with a humapen ergo teal with a clear cartridge holder.In either (b)(6) 2016, he began having problems with the humapen ergo.The cartridge holder of the humapen ergo could not connect tightly to the body of the pen ((b)(4)/lot 0402a02).On (b)(6) 2017, while using insulin lispro via the humapen ergo, he was hospitalized to have blood glucose adjust.Further hospitalization details were not provided.Information regarding corrective treatment and outcome of the events were not provided.Insulin lispro was continued.The patient was the operator of the humapen ergo and his training status was not provided.The humapen ergo model duration and suspect humapen ergo model duration of use was approximately four months.The humapen ergo device was returned on 31mar2017.The reporting consumer did not know if the events were related to insulin lispro treatment or humapen ergo device.The reporter refused to be contacted and did not give permission to contact the treating physician.Update 01-mar-2017: upon review, the case was opened to update the medwatch fields for regulatory reporting.Update 02-mar-2017: additional information received on 24-feb-2017 from the product complaint database added the product complaint (b)(4); added the product complaint information along with the time line for device use; updated the humapen ergo from an unknown body type to a humapen ergo teal with a clear cartridge holder; and updated the narrative.Update 07-mar-2017:on 28-feb-2017, two product complaint numbers associated with this case were received; however, the information had previously been entered in the case.No changes made to this case.Update 27mar2017: additional information received on 27mar2017 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields with the humapen ergo teal/clear device information, and the european and canadian (eu/ca) device information for the humapen ergo teal/clear.Added date of manufacturer.Corresponding fields and narrative updated accordingly.Update 25apr2017.Additional information received 24apr2017 from the product complaint safety database.On the device tab entered the device return date, changed malfunction to no, updated the device specific safety summary (dsss), updated the european and canadian (eu/ca) device information, updated the medwatch field with the device information and the narrative was updated accordingly.
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Search Alerts/Recalls
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