| Model Number MS9673A |
| Device Problems
Component Falling (1105); Excess Flow or Over-Infusion (1311); Insufficient Flow or Under Infusion (2182)
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| Patient Problems
Hyperglycemia (1905); Hypoglycemia (1912)
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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 product complaint and adverse event, concerns a pediatric male patient of unknown origin born (b)(6).Medical history: type i diabetes since 2014.Concomitant medication was not provided.The patient received insulin lispro (humalog) cartridge, six times a day, with dose variation according to food intake, unknown administration route, for type 1 diabetes, beginning in 2014.On a not provided date, unknown time after starting insulin lispro via humapen luxura half dose (unknown lot number), the patient experienced blood glucose peaks after device fell unintentionally on the floor.This case was associated with (b)(4).Information about corrective treatment and outcome from blood glucose peaks was not provided.On a non-reported date, patient experienced great frequency of hypoglycemia and hyperglycemia with no apparent reason, since the patient had a healthier life regarding alimentation and physical activities, was seen by endocrinologist and nutritionist every two months and had been keeping glycosylated hemoglobin at 6.8 (units and normal range not provided) for over a year.It was reported that on unknown dates, the patient had hypoglycemia of up to 33 (unit and reference value were not reported) several times.During the week of (b)(6) 2017, the events occurred again.The humapen luxura hd was tested and sometimes a lot of insulin was released and sometimes nothing came out; the reporting consumer realized then that the issue was the device itself ((b)(4)).Another humapen luxura hd of lot number unknown was acquired and the patient s glycemic levels returned to normal.It was provided that the first device not functioning well and its frailty put the patient s health and life at risk and therefore events of hypoglycemia and hyperglycemia were considered serious due to other medically significant reasons by the company.No information of corrective treatment was provided.The treatment with insulin lispro was continued.It was unknown who operated the device and if the operator was trained.The device model had been used for unspecified time and the reported device had been used for approximately one year.It was unknown if the use of the reported device was continued.The device return status was unknown.The initial consumer reporter did not provide an assessment of relatedness between the events and insulin lispro, however it was provided that the events was related to humapen luxura hd.Edit on 17mar2016: upon internal review on 17mar2016, entered product complaint number associated with the device.Update 09jun2017: additional information received from initial reporting consumer on 06jun2017.Updated reporter s name and add contact information.Added medical history of type 1 diabetes mellitus.Added laboratorial data of glycosylated hemoglobin 6.8.Added insulin lispro as suspect drug.Added another suspect device (humapen luxura hd) since there was another product complaint reported.Added serious events of hyperglycemia and hypoglycemia.Narrative and corresponding fields were updated accordingly.Update 14jun2017: additional information was received on 13jun2017 from the first reporting consumer.It was added frequency of therapy with insulin lispro, hypoglycemia value of 33 and product complaint number was added in the narrative.Narrative and corresponding fields were updated accordingly.Update 15jun2017.Additional information received on 14jun2017 from initial reporting consumer.Added information that the dose varied according to food intake; added age of reported device ; narrative and fields were updated accordingly.Edit 16jun2017.To enter medwatch device fields and european/canadian device for device mailing.No new information.
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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 report will be submitted when the final evaluation has been 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 product complaint and adverse event, concerns a pediatric male patient of unknown origin born on (b)(6).Medical history: type i diabetes since 2014.Concomitant medication was not provided.The patient received insulin lispro (humalog) cartridge, six times a day, with dose variation according to food intake, unknown administration route, for type 1 diabetes, beginning in 2014.On a not provided date, unknown time after starting insulin lispro via humapen luxura half dose (unknown lot number), the patient experienced blood glucose peaks after device fell unintentionally on the floor.This case was associated with (b)(4).Information about corrective treatment and outcome from blood glucose peaks was not provided.On a non-reported date, unknown time after starting treatment with insulin lispro via a new humapen luxura hd (lot number 1401g10), patient experienced great frequency of hypoglycemia and hyperglycemia with no apparent reason, since the patient had a healthier life regarding alimentation and physical activities, was seen by endocrinologist and nutritionist every two months and had been keeping glycosylated hemoglobin at 6.8 (units and normal range not provided) for over a year.It was reported that on unknown dates, the patient had hypoglycemia of up to 33 (unit and reference value were not reported) several times.During the week of (b)(6) 2017 to (b)(6) 2017, the events occurred again.The humapen luxura hd was tested and sometimes a lot of insulin was released and sometimes nothing came out; the reporting consumer realized then that the issue was the device itself ((b)(4)).A third humapen luxura hd of lot number unknown was acquired and the patient s glycemic levels returned to normal.It was provided that the second device not functioning well and its frailty put the patient s health and life at risk and therefore events of hypoglycemia and hyperglycemia were considered serious due to other medically significant reasons by the company.No information of corrective treatment was provided.The treatment with insulin lispro was continued.It was unknown who operated the humapen luxura hd and if the operator was trained.The humapen luxura hd model had been used for unspecified time; the reported device of lot number unknown had been used for unknown time and the reported device of lot number 1401g10 had been used for approximately one year.The use of device of lot number unknown was not intended to be continued, since it fell on the floor; it was unknown if the use of device of lot number 1401g10 was continued.The devices return status was unknown.The initial consumer reporter did not provide an assessment of relatedness between the events and insulin lispro, however it was provided that the events were related to humapen luxura hd.Edit on 17mar2016: upon internal review on 17mar2016, entered product complaint number associated with the device.Update 09jun2017: additional information received from initial reporting consumer on 06jun2017.Updated reporter s name and add contact information.Added medical history of type 1 diabetes mellitus.Added laboratorial data of glycosylated hemoglobin 6.8.Added insulin lispro as suspect drug.Added another suspect device (humapen luxura hd) since there was another product complaint reported.Added serious events of hyperglycemia and hypoglycemia.Narrative and corresponding fields were updated accordingly.Update 14jun2017: additional information was received on 13jun2017 from the first reporting consumer.It was added frequency of therapy with insulin lispro, hypoglycemia value of 33 and product complaint number was added in the narrative.Narrative and corresponding fields were updated accordingly.Update 15jun2017.Additional information received on 14jun2017 from initial reporting consumer.Added information that the dose varied according to food intake; added age of reported device ; narrative and fields were updated accordingly.Edit 16jun2017.To enter medwatch device fields and european/canadian device for device mailing.No new information.Edit 03jul2017: upon internal review of information received on 06jun2017, clarified information that the use of the first device of lot number unknown was not continued; clarified in the narrative that the second device of lot number 1401g10 was the device in use during the serious glycemic events and updated device paragraph to include this second device.Upon internal review of information received on 14jun2017, added lot number of second suspect device.
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Manufacturer Narrative
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No further follow up is planned.Evaluation summary: the mother of a male patient reported that her sons humapen luxura hd device was defective.She stated "i noticed that sometimes a lot of insulin came out and sometimes nothing came out, which made me realize that the problem was with the device." the patient experienced hypoglycemia and hyperglycemia.The device was not returned for investigation (batch 1401g10, manufactured january 2014).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.Troubleshooting of the device was attempted by a trained professional by having the reporter attach a new needle and dial to 30 units.The reporter stated no insulin was released.A complaint history review for the batch did not identify any atypical findings with regard to dose accuracy.All humapen luxura hd 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 or storage.
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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 product complaint and adverse event, concerns a pediatric male patient of unknown origin born on (b)(6).Medical history: type i diabetes since 2014.Concomitant medication was not provided.The patient received insulin lispro (humalog) cartridge, six times a day, with dose variation according to food intake, unknown administration route, for type 1 diabetes, beginning in 2014.On a not provided date, unknown time after starting insulin lispro via humapen luxura half dose (unknown lot number), the patient experienced blood glucose peaks after device fell unintentionally on the floor.This case was associated with product complaint number (b)(4).Information about corrective treatment and outcome from blood glucose peaks was not provided.On a non-reported date, unknown time after starting treatment with insulin lispro via a new humapen luxura hd (lot number 1401g10), patient experienced great frequency of hypoglycemia and hyperglycemia with no apparent reason, since the patient had a healthier life regarding alimentation and physical activities, was seen by endocrinologist and nutritionist every two months and had been keeping glycosylated hemoglobin at 6.8 (units and normal range not provided) for over a year.It was reported that on unknown dates, the patient had hypoglycemia of up to 33 (unit and reference value were not reported) several times.During the week of (b)(6) 2017 to (b)(6) 2017, the events occurred again.The humapen luxura hd was tested and sometimes a lot of insulin was released and sometimes nothing came out; the reporting consumer realized then that the issue was the device itself (product complaint number (b)(4) / lot number 1401g10).A third humapen luxura hd of lot number unknown was acquired and the patient s glycemic levels returned to normal.It was provided that the second device not functioning well and its frailty put the patient s health and life at risk and therefore events of hypoglycemia and hyperglycemia were considered serious due to other medically significant reasons by the company.No information of corrective treatment was provided.The treatment with insulin lispro was continued.It was unknown who operated the humapen luxura hd and if the operator was trained.The humapen luxura hd model had been used for unspecified time; the reported device of lot number unknown had been used for unknown time and the reported device of lot number 1401g10 had been used for approximately one year.The use of device of lot number unknown was not intended to be continued, since it fell on the floor; it was unknown if the use of device of lot number 1401g10 was continued.The device return status for the device of unknown lot number was not provided, the device associated with lot 1401g10 was not returned to the manufacturer.The initial consumer reporter did not provide an assessment of relatedness between the events and insulin lispro, however it was provided that the events were related to humapen luxura hd.Edit on 17mar2016: upon internal review on 17mar2016, entered product complaint number associated with the device.Update 09jun2017: additional information received from initial reporting consumer on 06jun2017.Updated reporter s name and add contact information.Added medical history of type 1 diabetes mellitus.Added laboratorial data of glycosylated hemoglobin 6.8.Added insulin lispro as suspect drug.Added another suspect device (humapen luxura hd) since there was another product complaint reported.Added serious events of hyperglycemia and hypoglycemia.Narrative and corresponding fields were updated accordingly.Update 14jun2017: additional information was received on 13jun2017 from the first reporting consumer.It was added frequency of therapy with insulin lispro, hypoglycemia value of 33 and product complaint number was added in the narrative.Narrative and corresponding fields were updated accordingly.Update 15jun2017.Additional information received on 14jun2017 from initial reporting consumer.Added information that the dose varied according to food intake; added age of reported device ; narrative and fields were updated accordingly.Edit 16jun2017.To enter medwatch device fields and european/(b)(6) device for device mailing.No new information.Edit 03jul2017: upon internal review of information received on 06jun2017, clarified information that the use of the first device of lot number unknown was not continued; clarified in the narrative that the second device of lot number 1401g10 was the device in use during the serious glycemic events and updated device paragraph to include this second device.Upon internal review of information received on 14jun2017, added lot number of second suspect device.Update 31jul2017: additional information received on 25jul2017 from the global product complaint database.Entered device specific safety summary (dsss); updated the medwatch fields with device information, the european and (b)(6) (eu/(b)(6)) device information, improper use and storage from yes to no; added date of manufacturer all for the suspect luxura hd device associated with product complaint (b)(4).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.Please refer to statement dated 28aug2017.No further follow up is planned.Evaluation summary: the mother of a male patient reported that her son's humapen luxura hd device was defective.She stated "i noticed that sometimes a lot of insulin came out and sometimes nothing came out, which made me realize that the problem was with the device." the patient experienced hypoglycemia and hyperglycemia.Investigation of the returned device (batch 1401g10, manufactured january 2014) found the device met functional requirements and met dose accuracy and glide (injection) force specifications.No malfunction was identified.There is no evidence of improper use or storage.
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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 product complaint and adverse event, concerns a pediatric male patient of unknown origin born on (b)(6) 2011.Medical history: type i diabetes since 2014.Concomitant medication was not provided.The patient received insulin lispro (humalog) cartridge, six times a day, with dose variation according to food intake, unknown administration route, for type 1 diabetes, beginning in 2014.On a not provided date, unknown time after starting insulin lispro via humapen luxura half dose (unknown lot number), the patient experienced blood glucose peaks after device fell unintentionally on the floor.This case was associated with product complaint number (b)(4).Information about corrective treatment and outcome from blood glucose peaks was not provided.On a non-reported date, unknown time after starting treatment with insulin lispro via a new humapen luxura hd (lot number 1401g10), patient experienced great frequency of hypoglycemia and hyperglycemia with no apparent reason, since the patient had a healthier life regarding alimentation and physical activities, was seen by endocrinologist and nutritionist every two months and had been keeping glycosylated hemoglobin at 6.8 (units and normal range not provided) for over a year.It was reported that on unknown dates, the patient had hypoglycemia of up to 33 (unit and reference value were not reported) several times.During the week of (b)(6) 2017 to (b)(6) 2017, the events occurred again.The humapen luxura hd was tested and sometimes a lot of insulin was released and sometimes nothing came out; the reporting consumer realized then that the issue was the device itself (product complaint number (b)(4) / lot number 1401g10).A third humapen luxura hd of lot number unknown was acquired and the patient s glycemic levels returned to normal.It was provided that the second device not functioning well and its frailty put the patient s health and life at risk and therefore events of hypoglycemia and hyperglycemia were considered serious due to other medically significant reasons by the company.No information of corrective treatment was provided.The treatment with insulin lispro was continued.It was unknown who operated the humapen luxura hd and if the operator was trained.The humapen luxura hd model had been used for unspecified time; the reported device of lot number unknown had been used for unknown time and the reported device of lot number 1401g10 had been used for approximately one year.The use of device of lot number unknown was not intended to be continued, since it fell on the floor; it was unknown if the use of device of lot number 1401g10 was continued.The device return status for the device of unknown lot number was not provided, the device associated with lot 1401g10 was returned to the manufacturer on 07aug2017.The initial consumer reporter did not provide an assessment of relatedness between the events and insulin lispro, however it was provided that the events were related to humapen luxura hd.Edit on 17mar2016: upon internal review on 17mar2016, entered product complaint number associated with the device.Update 09jun2017: additional information received from initial reporting consumer on (b)(6) 2017.Updated reporter s name and add contact information.Added medical history of type 1 diabetes mellitus.Added laboratorial data of glycosylated hemoglobin 6.8.Added insulin lispro as suspect drug.Added another suspect device (humapen luxura hd) since there was another product complaint reported.Added serious events of hyperglycemia and hypoglycemia.Narrative and corresponding fields were updated accordingly.Update 14jun2017: additional information was received on 13jun2017 from the first reporting consumer.It was added frequency of therapy with insulin lispro, hypoglycemia value of 33 and product complaint number was added in the narrative.Narrative and corresponding fields were updated accordingly.Update 15jun2017.Additional information received on 14jun2017 from initial reporting consumer.Added information that the dose varied according to food intake; added age of reported device ; narrative and fields were updated accordingly.Edit 16jun2017.To enter medwatch device fields and european/(b)(6) devicefor device mailing.No new information.Edit 03jul2017: upon internal review of information received on (b)(6) 2017, clarified information that the use of the first device of lot number unknown was not continued; clarified in the narrative that the second device of lot number 1401g10 was the device in use during the serious glycemic events and updated device paragraph to include this second device.Upon internal review of information received on 14jun2017, added lot number of second suspect device.Update 31jul2017: additional information received on 25jul2017 from the global product complaint database.Entered device specific safety summary (dsss); updated the medwatch fields with device information, the european and (b)(6) (eu/(b)(6)) device information, improper use and storage from yes to no; added date of manufacturer all for the suspect luxura hd device associated with product complaint (b)(4).Corresponding fields and narrative updated accordingly.Update 28aug2017: additional information received on 25aug2017 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields with device information, the european and (b)(6) (eu/(b)(6)) device information, improper use and storage from yes to no, malfunction from unknown to no, and device return status to returned to manufacturer.Added date returned to manufacturer for the device.Corresponding fields and narrative updated accordingly.
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Search Alerts/Recalls
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