Model Number MS9557 |
Device Problems
Fluid/Blood Leak (1250); Physical Resistance/Sticking (4012)
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Patient Problems
Fatigue (1849); Headache (1880); Hyperglycemia (1905); Blurred Vision (2137)
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Event Date 06/17/2020 |
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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Lilly case id: (b)(4).This report is associated with product complaint: (b)(4).This solicited case, reported by a consumer via a patient support program (psp), with additional information from initial reporting consumer via a psp, concerned a (b)(6) year-old female patient of unspecified ethnicity.Medical history included diabetes since before 1990.Concomitant medication was not provided.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) injections (humulin 70/30) via reusable device (humapen ergo ii), subcutaneously, for treatment of diabetes, beginning on an unknown date since before 1990.Dosage regimen was not provided.On approximately (b)(6) 2020 or (b)(6) 2020, after starting human insulin isophane suspension 70%/human insulin 30% therapy, the screw of humapen ergo ii got stuck and the screw did not push the plunger to release the human insulin isophane suspension 70%/human insulin 30%.Reportedly, the needles were changed every other day, as she was dispensed only 15 needles from hospital (improper use of device).There was human insulin isophane suspension 70%/human insulin 30% leakage (pc 5201679/ lot number unknown) which was the cause that she suffered from high blood glucose (no values and reference ranges were provided).Since an unknown date, she suffered from high blood pressure (no values and reference ranges were provided) which was correlative with high blood glucose and it started after taking the human insulin isophane suspension 70%/human insulin 30%, she changed many drugs for high blood pressure.She was taking her doses using insulin syringe since pen got impaired.With insulin syringe, it was difficult for her to take her doses as she could not adjust the dose (suspicious of inaccurate dose) and that led to the following high blood glucose.On an unknown date she was very tired and due to high blood glucose, which reached 228 mg/dl last time they measured, she suffered from headache and blurry vision.As long as blood glucose increased, the blood pressure increased reaching last time measured 140/90 mmhg.She went to the hospital many times due to the events of high blood glucose and high blood pressure, but was not hospitalized due to coronavirus situation as hospital refused to hospitalize her.The events were considered serious due to medical significance.The outcome of event tiredness was unknown while she did not recover from the remaining events.Information regarding further corrective treatment was not provided.Human insulin isophane suspension 70%/human insulin 30% was ongoing.The operator of the humapen ergo ii and his/her training status were not provided.The humapen ergo ii model duration of use and the suspect humapen ergo ii duration of use were not provided.The use of the suspect humapen ergo ii was discontinued and its return was expected.The reporting consumer did not provide a relatedness assessment for the events to human insulin isophane suspension 70%/human insulin 30% therapy.The reporting consumer related the event of incorrect dose administered with insulin syringe and did not provide the relatedness of event tiredness with humapen ergo ii while related the remaining events with the humapen ergo ii issue.Update 09-jul-2020: additional information was received from initial reporting consumer via a psp on (b)(6) 2020.Added: four non-serious events of incorrect dose administered, fatigue, headache and vision blurred, two laboratory test of blood glucose and blood pressure.Updated: as reported verbatim of events blood glucose increased and blood pressure increased.Causality statement and narrative was updated with new information accordingly.Edit 10jul2020: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.
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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 a patient support program (psp), with additional information from initial reporting consumer via a psp, concerned a 70-year-old female patient of unspecified ethnicity.Medical history included diabetes since before 1990.Concomitant medication was not provided.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) injections (humulin 70/30) via reusable device (humapen ergo ii), subcutaneously, for treatment of diabetes, beginning on an unknown date since before 1990.Dosage regimen was not provided.On approximately (b)(6) 2020, after starting human insulin isophane suspension 70%/human insulin 30% therapy, the screw of humapen ergo ii got stuck and the screw did not push the plunger to release the human insulin isophane suspension 70%/human insulin 30%.Reportedly, the needles were changed every other day, as she was dispensed only 15 needles from hospital (improper use of device).There was human insulin isophane suspension 70%/human insulin 30% leakage ((b)(4)/ lot number unknown) which was the cause that she suffered from high blood glucose (no values and reference ranges were provided).Since an unknown date, she suffered from high blood pressure (no values and reference ranges were provided) which was correlative with high blood glucose and it started after taking the human insulin isophane suspension 70%/human insulin 30%, she changed many drugs for high blood pressure.She was taking her doses using insulin syringe since pen got impaired.With insulin syringe, it was difficult for her to take her doses as she could not adjust the dose (suspicious of inaccurate dose) and that led to the following high blood glucose.On an unknown date she was very tired and due to high blood glucose, which reached 228 mg/dl last time they measured, she suffered from headache and blurry vision.As long as blood glucose increased, the blood pressure increased reaching last time measured 140/90 mmhg.She went to the hospital many times due to the events of high blood glucose and high blood pressure, but was not hospitalized due to coronavirus situation as hospital refused to hospitalize her.The events were considered serious due to medical significance.The outcome of event tiredness was unknown while she did not recover from the remaining events.Information regarding further corrective treatment was not provided.Human insulin isophane suspension 70%/human insulin 30% was ongoing.The operator of the humapen ergo ii and his/her training status were not provided.The humapen ergo ii model duration of use and the suspect humapen ergo ii duration of use were not provided.The use of the suspect humapen ergo ii was discontinued and was not returned to the manufacturer.The reporting consumer did not provide a relatedness assessment for the events to human insulin isophane suspension 70%/human insulin 30% therapy.The reporting consumer related the event of incorrect dose administered with insulin syringe and did not provide the relatedness of event tiredness with humapen ergo ii while related the remaining events with the humapen ergo ii issue.Update 09-jul-2020: additional information was received from initial reporting consumer via a psp on 05-jul-2020.Added: four non-serious events of incorrect dose administered, fatigue, headache and vision blurred, two laboratory test of blood glucose and blood pressure.Updated: as reported verbatim of events blood glucose increased and blood pressure increased.Causality statement and narrative was updated with new information accordingly.Edit 10jul2020: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 20jul2020: additional information received on 20jul2020 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields/ european and canadian (eu/ca) device information and device return status to not returned to manufacturer for (b)(4) associated with unknown lot of a humapen ergo ii device.Corresponding fields and narrative updated accordingly.
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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(s) dated 20jul2020 in the b.5.Field.No further follow-up is planned.Evaluation summary a female patient reported that the injection screw of her humapen ergo ii device got stuck and the screw did not push the plunger to release the insulin.On an unknown date, she experienced increased blood glucose.The device was not returned to the manufacturer for investigation (batch unknown).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.All humapen devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality.The patient reported changing the injection pen needle every other day.The core instructions for use states to use a new needle for each injection.There is evidence of improper use.The patient reused needles.This misuse may be relevant to the complaint and the event of increased blood glucose.
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Search Alerts/Recalls
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