Model Number MS9673A |
Device Problems
Difficult or Delayed Activation (2577); Mechanical Jam (2983)
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Patient Problem
Hyperglycemia (1905)
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Event Date 04/29/2022 |
Event Type
Injury
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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 patient support program (psp), concerns a (b)(6) female patient of an unknown origin.Medical history included diabetes and occasional wounds.Concomitant medication included insulin glargine and human insulin nph for diabetes, levothyroxine for thyroid, gabapentin for loss of feeling in the feet and vitamin d for unknown indication.The patient received insulin human (rdna origin) lispro (humalog) cartridge via humapen luxura hd, dose and frequency varied according to carbohydrate count, for diabetes, subcutaneously, beginning on (b)(6) 2020.On an unspecified date, approximately for the last month before the report while on insulin human, the back part of her pen was pressing very hard, as reported.On (b)(6) 2022, the reporting day, it the device was locked and dose was missed while applying it in the morning (product complaint tr (b)(4); lot number 1808g01).On the same day at 4 pm, the patients blood sugar was elevated to 480 (units and normal range were not provided), she was hospitalized due to this event and the lunch dose was administered in the hospital with an insulin injector.Additionally, at an unknown date while in insulin human, wounds in feet were opened because of the patients high blood sugar.The events of wounds opened was considered serious by the company due to medically significant reasons.The patient would be hospitalized for 3 to 4 days after the reporting day.Information regarding corrective treatments, additional laboratorial exams and the outcome of the events were not provided.Treatment with insulin lispro was ongoing.It was unknown who operated the device and if the operator was trained.The duration for use for the device model was approximately two years and the duration of the reported suspect device was not provided.Action taken and return status of device were unknown.The reporting consumer related missed dose was due to device issue.No other relatedness opinion was provided.Update 09may2022: upon internal review of information received on 29apr2022, removed serious criteria of intervention required for the event of blood glucose increased.Updated medwatch fields for expedited device reporting and added contact log accordingly.No new information added.
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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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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 update statement dated 27may2022 in the b.5.Field.No further follow-up is planned.Evaluation summary: the mother of a female patient reported that the back part of the patient's humapen luxura hd device was pressing hard for several months.On (b)(6) 2022, the device was locked, and the patient missed her dose.The patient experienced increased blood glucose.The device was not returned to the manufacturer for investigation (batch 1808g01, manufactured august 2018).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.All humapen luxura hd devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality with high probability.A complaint history review of the batch did not identify any atypical findings with regard to pen jam issues.The core instructions for use states to always carry a spare insulin pen in case your pen is lost or damaged.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 report is associated with product complaint: (b)(4).This solicited case, reported by a consumer via patient support program (psp), concerns a 13-year-old female patient of an unknown origin.Medical history included diabetes and occasional wounds.Concomitant medication included insulin glargine and human insulin nph for diabetes, levothyroxine for thyroid, gabapentin for loss of feeling in the feet and vitamin d for unknown indication.The patient received insulin human (rdna origin) lispro (humalog) cartridge via humapen luxura hd, dose and frequency varied according to carbohydrate count, for diabetes, subcutaneously, beginning on (b)(6) 2020.On an unspecified date, approximately for the last month before the report while on insulin human, the back part of her pen was pressing very hard, as reported.On (b)(6) 2022, the reporting day, it the device was locked and dose was missed while applying it in the morning (product complaint tr (b)(4); lot number 1808g01).On the same day at 4 pm, the patients blood sugar was elevated to 480 (units and normal range were not provided), she was hospitalized due to this event and the lunch dose was administered in the hospital with an insulin injector.Additionally, at an unknown date while in insulin human, wounds in feet were opened because of the patients high blood sugar.The events of wounds opened was considered serious by the company due to medically significant reasons.The patient would be hospitalized for 3 to 4 days after the reporting day.Information regarding corrective treatments, additional laboratorial exams and the outcome of the events were not provided.Treatment with insulin lispro was ongoing.It was unknown who operated the device and if the operator was trained.The duration for use for the device model was approximately two years and the duration of the reported suspect device was not provided.Action taken and device was not returned to the manufacturer for investigation.The reporting consumer related missed dose was due to device issue.No other relatedness opinion was provided.Update 09may2022: upon internal review of information received on 29apr2022, removed serious criteria of intervention required for the event of blood glucose increased.Updated medwatch fields for expedited device reporting and added contact log accordingly.No new information added.Update 27may2022: additional information received on 26may2022 from the global product complaint database.Entered device specific safety summary (dsss) for humapen luxura hd,device associated with pc (b)(4), lot 1808g01.Updated the medwatch fields/ european and canadian (eu/ca) device information and device return status to not returned to manufacturer.Added date of manufacturer and unique device identifier (udi) for the device.Corresponding fields and narrative updated accordingly.
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Search Alerts/Recalls
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